Primeline Medical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Primeline Medical Products, Inc.” (first 1997, latest 2002), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
Review panels
Most recent Primeline Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023266 | PRIMAGARD SURGICAL GOWNS | FYA | 2002-11-08 | 39 |
| K023117 | PRIMAGARD SURGICAL GOWNS | KKX | 2002-11-08 | 58 |
| K022868 | PRIMAGARD SURGICAL EQUIPMENT DRAPES | KKX | 2002-11-08 | 71 |
| K021864 | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | KKX | 2002-09-23 | 109 |
| K021076 | PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM | FXX | 2002-04-16 | 13 |
| K011789 | PROCEDURE MASKS: PM4-301 AND PM4-304 | FXX | 2001-06-22 | 14 |
| K001951 | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | FXX | 2000-09-08 | 73 |
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | FXP | 1998-01-13 | 295 |
| K971075 | PRIMED PRIME-PLUS COTTON GAUZE SPONGES | EFQ | 1997-06-22 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Primeline 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.
- Primeline Industries, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Primeline Medical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Primeline Medical Products, Inc.” (first 1997, latest 2002), across 5 product codes in 2 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 Primeline Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Primeline Medical Products, Inc. is 71 days.
Which FDA product codes appear under Primeline Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are FXX (Mask, Surgical, 3); KKX (Drape, Surgical, Antimicrobial, 3); EFQ (Gauze/Sponge, Internal, 1).
Next steps
- See all 9 Primeline Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FXX, Primeline 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.