Honsun (Nantong) Co., Ltd. FDA Record
- Latest inspection VAI · Jan 16, 2014
- No warning letters matched by name
Honsun (Nantong) Co., Ltd. has 0 FDA recalls, 1 inspection, 13 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Honsun (Nantong) Co., Ltd." is on file.
- Latest inspection
- Jan 16, 2014 · VAI
- Latest 510(k)
- Aug 31, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 13 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 16, 2014 | Nantong City, China | Devices | Voluntary Action Indicated (VAI) | 3007740533 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007740533 | Nantong City, China | 1 | Jan 16, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Aug 31, 2026 |
| K252399 | Portable Oxygen Concentrator | Jun 17, 2026 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 &… | Apr 28, 2026 |
| K251795 | Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) | Oct 9, 2025 |
| K211629 | Infrared forehead thermometer LD-FT-100B | Dec 8, 2021 |
| K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Apr 6, 2020 |
| K170866 | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 | Feb 21, 2018 |
| K170466 | Automatic Blood Pressure Monitor Model LD-518 & LD-537 | Oct 27, 2017 |
| K170454 | Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U | Oct 25, 2017 |
| K132627 | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Oct 23, 2013 |
| K130925 | AUTOMATIC BLOOD PRESSURE MONITOR | Sep 12, 2013 |
| K131463 | WRIST AUTOMATIC BLOOD PRESSURE MONITOR | Jul 8, 2013 |
| K092245 | ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 | Oct 28, 2009 |
Honsun (Nantong) Co., Ltd. and the FDA: common questions
Has Honsun (Nantong) Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Honsun (Nantong) Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Honsun (Nantong) Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Honsun (Nantong) Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Honsun (Nantong) Co., Ltd.?
The most recent FDA inspection on file ended Jan 16, 2014 at Nantong City, China and was classified VAI. FDA has 1 inspection of Honsun (Nantong) Co., Ltd. on file.
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