Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Avail Medical Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
84 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2011-09-08 | 38 | 0 |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2009-04-15 | 84 | 0 |
| K083189 | STERI-LUB LUBRICATION GEL | Avail Medical Products, Inc. | 2008-11-21 | 23 | 0 |
| K030149 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, M | Avail Medical Products, Inc. | 2003-03-20 | 64 | 1 |
| K030137 | MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, M | Avail Medical Products, Inc. | 2003-02-19 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda