Bionet Co., Ltd. FDA Record
- Latest inspection VAI · Feb 21, 2019
- Last warning letter 2011
Bionet Co., Ltd. has 0 FDA recalls, 4 inspections, 14 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Bionet Co., Ltd., the most recent on Jul 27, 2011.
- Latest inspection
- Feb 21, 2019 · VAI
- Latest 510(k)
- Dec 15, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 14 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Bionet Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Bionet Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Bionet Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Jul 27, 2011 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 21, 2019 | Anyang, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3003681187 |
| Jan 17, 2013 | Anyang, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3003681187 |
| Apr 21, 2011 | Anyang, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3003681187 |
| Apr 21, 2011 | Anyang, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3003681187 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Bionet Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003681187 | Anyang, Korea (The Republic Of) | 4 | Feb 21, 2019 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K231160 | Cardio Q50, Cardio Q70 | Dec 15, 2023 |
| K231150 | Cardio P1 | Nov 9, 2023 |
| K220535 | Cardio10 | Nov 15, 2022 |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L)… | Oct 11, 2022 |
| K130322 | SPM-300 | Nov 15, 2013 |
| K113306 | CARDIO 7 | Jul 16, 2012 |
| K102767 | CARDIO XP | Jun 3, 2011 |
| K090895 | EKG-PLUS II SOFTWARE | Aug 26, 2009 |
| K082008 | BIONET BM3PLUS PATIENT MONITOR | Dec 11, 2008 |
| K043598 | FC 1400 FETAL MONITOR | Dec 16, 2005 |
| K043597 | FC 700 FETAL MONITOR | Dec 16, 2005 |
| K023082 | BABYCARE | Mar 3, 2003 |
| K023034 | CARDIOTOUCH-3000 | Nov 14, 2002 |
| K011328 | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH | Nov 21, 2001 |
Bionet Co., Ltd. and the FDA: common questions
Has Bionet Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Bionet Co., Ltd.. The most recent is dated Jul 27, 2011.
Has Bionet Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Bionet Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Bionet Co., Ltd.?
The most recent FDA inspection on file ended Feb 21, 2019 at Anyang, Korea (The Republic Of) and was classified VAI. FDA has 4 inspections of Bionet Co., Ltd. on file.
Need more than this page shows? Ask about Bionet Co., Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.