Primed Medical Products, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Primed Medical Products, Inc.” (first 2008, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 92 days, against 154 days for all cleared 510(k)s in the same product codes. 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 | 1 | 269 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 397 |
| 2023 | 0 | — |
| 2024 | 3 | 182 |
| 2025 | 1 | 48 |
| 2026 | 2 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Primed Medical Products, Inc. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FXX | Mask, Surgical | 4 | 4 |
| FRG | Wrap, Sterilization | 2 | 2 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| OXZ | Pediatric/Child Facemask | 1 | 1 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 1 | 1 |
| QSO | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | 1 | 1 |
Review panels
- General Hospital (10)
Most recent Primed Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262007 | PRIMED AAMI Level 3 Open Back Gowns | QPC | 2026-09-11 | 88 |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | QSO | 2026-09-01 | 92 |
| K252964 | PRIMED Surgical and Procedure Masks | FXX | 2025-11-04 | 48 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | 2024-10-07 | 70 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | FXX | 2024-08-26 | 207 |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | 2024-05-24 | 182 |
| K213427 | PRIMED Pediatric Facemask | OXZ | 2022-11-22 | 397 |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | FYC | 2016-11-04 | 269 |
| K092012 | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 | FXX | 2009-09-25 | 81 |
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | FXX | 2008-08-11 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Primed 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.
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.
- Primed, Inc. (1 510(k)s)
- Primed Halberstadt Medizintechnik GmbH (1 510(k)s)
- Primed Instruments, Inc. (1 510(k)s)
- Primed Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Primed Medical Products, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Primed Medical Products, Inc.” (first 2008, latest 2026), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Primed Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Primed Medical Products, Inc. is 90 days. Since 2017: 92 days, versus 154 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Primed Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 4); FRG (Wrap, Sterilization, 2); FYC (Gown, Isolation, Surgical, 1).
Next steps
- See all 10 Primed Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Primed 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.