Primrose Medical, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Primrose Medical, Inc.” (first 1984, latest 1989), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| KNQ | Dilator, Esophageal | 2 | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 | 1 |
| BZW | Stethoscope, Esophageal | 1 | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 | 1 |
| FFP | Dilator, Rectal | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GES | Blade, Scalpel | 1 | 1 |
Plus 3 more product codes.
Review panels
- Gastroenterology and Urology (7)
- General Hospital (3)
- Anesthesiology (2)
- General and Plastic Surgery (2)
Most recent Primrose Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884715 | ACHELASIA BALLOON DIALATOR | KNQ | 1989-09-29 | 325 |
| K884714 | BILIARY DIALATOR | FGE | 1989-09-29 | 325 |
| K884713 | COLONIC BALLOON DIALATORS | FFP | 1989-09-29 | 325 |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | EZN | 1989-09-29 | 325 |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | KNQ | 1989-09-08 | 304 |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | ODD | 1989-09-08 | 304 |
| K883420 | LANCET, BLOOD | FMK | 1988-08-26 | 11 |
| K881976 | CATHETER, INTRAVASCULAR | FOZ | 1988-08-04 | 85 |
| K881977 | PRESSURE INFUSOR | KZD | 1988-07-29 | 79 |
| K881975 | SET, INTRAVASCULAR | FPA | 1988-07-29 | 79 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Primrose Medical, 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 Primrose Medical, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Primrose Medical, Inc.” (first 1984, latest 1989), across 13 product codes in 4 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 Primrose Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Primrose Medical, Inc. is 82 days.
Which FDA product codes appear under Primrose Medical, Inc.?
The most frequent FDA product codes under this applicant name are KNQ (Dilator, Esophageal, 2); BZT (Stethoscope, Esophageal, With Electrical Conductors, 1); BZW (Stethoscope, Esophageal, 1).
Next steps
- See all 14 Primrose Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNQ, Primrose Medical, 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.