Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pyng Medical Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
224 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130487 | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE | Pyng Medical Corp. | 2013-06-25 | 120 | 0 |
| K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE | Pyng Medical Corp. | 2010-08-31 | 224 | 1 |
| K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | Pyng Medical Corp. | 2008-04-24 | 27 | 0 |
| K072487 | FAST1 INTRAOSSEOUS INFUSION SYSTEM | Pyng Medical Corp. | 2008-02-13 | 162 | 0 |
| K970380 | F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM | Pyng Medical Corp. | 1997-04-25 | 81 | 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