Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Baxa Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
198 daysmedian FDA review time
324 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090917 | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Baxa Corp. | 2010-02-19 | 324 | 0 |
| K070163 | SWABBABLE CAP, MODEL 60205 | Baxa Corp. | 2007-08-03 | 198 | 0 |
| K062909 | REPEATER PUMP II TUBE SETS | Baxa Corp. | 2007-03-09 | 163 | 0 |
| K022523 | RAPID-FILL TUBESET, MODEL 90005 | Baxa Corp. | 2002-08-12 | 13 | 0 |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | Baxa Corp. | 2001-03-28 | 210 | 11 |
| K983321 | MICROFUSE DUAL RATE INFUSER | Baxa Corp. | 1998-10-06 | 14 | 0 |
| K951871 | PISTON SYRINGE | Baxa Corp. | 1995-06-21 | 61 | 0 |
| K933506 | SYRINGE INFUSER | Baxa Corp. | 1994-02-25 | 220 | 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