Professional Medical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Professional Medical Products, Inc.” (first 1982, latest 1994), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| LRO | General Surgery Tray | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| KXJ | Table, Radiologic | 1 | 1 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Professional Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926280 | STANDARD NEBULIZER HEATER | CAF | 1994-03-22 | 463 |
| K930270 | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE | LRO | 1994-02-17 | 394 |
| K920292 | VARIOUS KITS AND TRAYS | LRO | 1994-01-26 | 735 |
| K862010 | CHICK SURGICAL LIGHT | FTA | 1986-06-09 | 12 |
| K860739 | CHICK SURIGICAL LIGHT | FSY | 1986-03-28 | 29 |
| K834478 | CHICK/REISON PATIENT EMERG. TROLLEY | KXJ | 1984-02-21 | 63 |
| K830825 | YIELD NON-ADHERENT DRESSING | FRO | 1983-05-13 | 59 |
| K822713 | DERM-A-TEC SKIN BARRIER FILM | — | 1982-12-07 | 91 |
| K820413 | AEGIS NON-ADHERENT DRESSING | NAB | 1982-03-12 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Professional Medical Products, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Professional Medical Products, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Professional Medical Services (19 510(k)s)
- Professional Instruments Co. (3 510(k)s)
- Professional Latex Sdn Bhd (3 510(k)s)
- Professional Positioners, Inc. (3 510(k)s)
- Professional Dental Mfg., Inc. (2 510(k)s)
- Professional Services For Surgeons, Ltd. (2 510(k)s)
- Professional Supplies, Inc. (2 510(k)s)
- Professional Tape Co., Inc. (2 510(k)s)
- Professional Technologies Corp. (2 510(k)s)
- Professional Catheter Corp. (1 510(k)s)
- Professional Dental Studios (1 510(k)s)
- Professional Dental Technologies Therapeutics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Professional Medical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Professional Medical Products, Inc.” (first 1982, latest 1994), across 8 product codes in 3 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 Professional Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Professional Medical Products, Inc. is 63 days.
Which FDA product codes appear under Professional Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are LRO (General Surgery Tray, 2); CAF (Nebulizer (Direct Patient Interface), 1); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 9 Professional Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LRO, Professional Medical Products, 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.