Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gettig Pharmaceutical Instrument Co. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
89 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041232 | GETTIG UNIVERSAL VIAL ACCESS PIN | Gettig Pharmaceutical Instrument Co. | 2004-07-22 | 73 | 0 |
| K033409 | AMERSHAM HEALTH NEEDLE-GUARD | Gettig Pharmaceutical Instrument Co. | 2004-01-21 | 89 | 0 |
| K022495 | GETTIG DISPOSABLE SYRINGES | Gettig Pharmaceutical Instrument Co. | 2002-10-08 | 71 | 0 |
| K000455 | GETTIG GUARD | Gettig Pharmaceutical Instrument Co. | 2000-04-19 | 68 | 0 |
| K972285 | GETTIG STYRL-JECT DELIVERY SYSTEM | Gettig Pharmaceutical Instrument Co. | 1997-09-11 | 84 | 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