Avail Medical Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Avail Medical Products, Inc.” (first 2003, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| KNY | Accessories, Catheter, G-U | 2 | 2 |
| KMJ | Lubricant, Patient | 1 | 1 |
Review panels
Most recent Avail Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | KNY | 2011-09-08 | 38 |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | KNY | 2009-04-15 | 84 |
| K083189 | STERI-LUB LUBRICATION GEL | KMJ | 2008-11-21 | 23 |
| K030149 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 | FPA | 2003-03-20 | 64 |
| K030137 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 | FPA | 2003-02-19 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Avail 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 Avail Medical Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Avail Medical Products, Inc.” (first 2003, latest 2011), across 3 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 Avail Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avail Medical Products, Inc. is 38 days.
Which FDA product codes appear under Avail Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); KNY (Accessories, Catheter, G-U, 2); KMJ (Lubricant, Patient, 1).
Next steps
- See all 5 Avail Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Avail 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.