Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Habley Medical Technology Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
128 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955164 | S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM) | Habley Medical Technology Corp. | 1996-03-20 | 128 | 0 |
| K903007 | MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER | Habley Medical Technology Corp. | 1990-09-19 | 70 | 0 |
| K881980 | RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE | Habley Medical Technology Corp. | 1988-06-28 | 47 | 0 |
| K880594 | VACUGUARD(TM) | Habley Medical Technology Corp. | 1988-04-28 | 77 | 0 |
| K871007 | ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE | Habley Medical Technology Corp. | 1987-04-30 | 48 | 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