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Hangzhou Jinlin Medical Appliances Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Mar 19, 2025
Last warning letter 2012

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Dec 13, 2012

510(k) clearances 1 Latest Jul 9, 2015

Hangzhou Jinlin Medical Appliances Co., Ltd. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Hangzhou Jinlin Medical Appliances Co., Ltd., the most recent on Dec 13, 2012.

What these totals cover: FDA records filed under the name "Hangzhou Jinlin Medical Appliances Co., Ltd." and its spelling variant "Hangzhou Jinlin Medical Appliances Co".

Latest inspection: Mar 19, 2025 · NAI
Latest 510(k): Jul 9, 2015

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	1	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Hangzhou Jinlin Medical Appliances Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Hangzhou Jinlin Medical Appliances Co., Ltd.: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Hangzhou Jinlin Medical Appliances Co., Ltd. FDA Warning Letters

1 warning letter on Dec 13, 2012.

Issued	Subject	Issuing office	Close-out letter
Dec 13, 2012 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Jul 26, 2012 to Mar 19, 2025.

Date	Site	Product	Classification	FEI
Mar 19, 2025	Hangzhou, China	Devices	No Action Indicated (NAI)	3004056932
Nov 1, 2018	Hangzhou, China	Devices	No Action Indicated (NAI)	3004056932
Jul 26, 2012	Hangzhou, China	Devices	Official Action Indicated (OAI)	3004056932

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Hangzhou Jinlin Medical Appliances Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 13, 2012.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004056932	Hangzhou, China	3	Mar 19, 2025

Recent 510(k) clearances

1 510(k) clearance on Jul 9, 2015.

K-Number	Device	Date
K142764	KYOLING CPR Mask with Oxygen Port and Without Oxygen Port	Jul 9, 2015

Hangzhou Jinlin Medical Appliances Co., Ltd. and the FDA: common questions

Has Hangzhou Jinlin Medical Appliances Co., Ltd. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Hangzhou Jinlin Medical Appliances Co., Ltd.. The most recent is dated Dec 13, 2012.

Has Hangzhou Jinlin Medical Appliances Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Hangzhou Jinlin Medical Appliances Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Hangzhou Jinlin Medical Appliances Co., Ltd.?

The most recent FDA inspection on file ended Mar 19, 2025 at Hangzhou, China and was classified NAI. FDA has 3 inspections of Hangzhou Jinlin Medical Appliances Co., Ltd. on file, 1 of them classified OAI (official action indicated).

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