Zee Medical Products Co., Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Zee Medical Products Co., Inc.” (first 1981, latest 1983), across 8 product codes in 6 review panels. Median 510(k) review time under this name: 32 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GDZ | Handle, Scalpel | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
| HQZ | Frame, Spectacle | 1 | 1 |
| HST | Apparatus, Traction, Non-Powered | 1 | 1 |
| IQF | Orthosis, Cervical-Thoracic, Rigid | 1 | 1 |
| LHX | Trousers, Anti-Shock | 1 | 1 |
Review panels
- Cardiovascular (2)
- Neurology (2)
- Anesthesiology (1)
- Ophthalmic (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Zee Medical Products Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K823501 | ZEE SPHYGMOMANOMETER | DXN | 1983-01-21 | 58 |
| K813156 | ULTRA-WIDE SAFETY SPECTACLE FRAME | HQZ | 1981-12-14 | 38 |
| K813016 | ZEE TRACTION SPLINT | HST | 1981-11-24 | 28 |
| K812814 | ZEE SURGICAL INSTRUMENTS | GDZ | 1981-11-06 | 31 |
| K812564 | ZEE LIFE SUPPORT AIR PANTS | LHX | 1981-10-23 | 45 |
| K812342 | ZEE EXTRICATION DEVICE | IQF | 1981-09-21 | 34 |
| K812284 | ZEE ELECTRODE-GEL | GYB | 1981-09-08 | 26 |
| K812022 | ZEE MANUAL RESUSCITATOR | BTM | 1981-07-31 | 11 |
Recalls
openFDA lists no recalls under a recalling firm named Zee Medical Products Co., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Zee Medical Products Co., Inc.?
FDA lists 8 510(k) clearances under the applicant name “Zee Medical Products Co., Inc.” (first 1981, latest 1983), across 8 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Zee Medical Products Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zee Medical Products Co., Inc. is 32 days.
Which FDA product codes appear under Zee Medical Products Co., Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1); GDZ (Handle, Scalpel, 1).
Next steps
- See all 8 Zee Medical Products Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Zee Medical Products Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.