Atrion Medical Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Atrion Medical Products, Inc.” (first 1997, latest 2006), across 7 product codes in 6 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| KOE | Dilator, Urethral | 2 | 2 |
| OKS | Lacrimal Stents And Intubation Sets | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- General Hospital (2)
- Ophthalmic (2)
- Anesthesiology (1)
- Cardiovascular (1)
- Dental (1)
Most recent Atrion Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K060643 | QL LOCKING SYRINGE | MAV | 2006-07-12 | 124 |
| K043249 | ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE | FMI | 2005-05-25 | 183 |
| K041158 | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM | CAZ | 2004-06-16 | 44 |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | 2004-03-03 | 174 |
| K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE | DXT | 2002-04-25 | 84 |
| K973633 | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET | OKS | 1998-01-16 | 183 |
| K973872 | ATRION MEDICAL COATED LACRIMAL INTUBATION SET | OKS | 1998-01-08 | 90 |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | KOE | 1997-10-10 | 60 |
| K971100 | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR | EIA | 1997-05-23 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Atrion 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Atrion Medical Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Atrion Medical Products, Inc.” (first 1997, latest 2006), across 7 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 Atrion Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atrion Medical Products, Inc. is 90 days.
Which FDA product codes appear under Atrion Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are KOE (Dilator, Urethral, 2); OKS (Lacrimal Stents And Intubation Sets, 2); CAZ (Anesthesia Conduction Kit, 1).
Next steps
- See all 9 Atrion Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOE, Atrion 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.