Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Harvard Apparatus, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
319 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970678 | THE HARVARD LIBRARY | Harvard Apparatus, Inc. | 1998-01-09 | 319 | 0 |
| K952794 | HARVARD 2 SYRINGE PUMP | Harvard Apparatus, Inc. | 1995-09-15 | 88 | 2 |
| K903614 | HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE | Harvard Apparatus, Inc. | 1990-12-14 | 127 | 0 |
| K903613 | HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) | Harvard Apparatus, Inc. | 1990-11-07 | 90 | 0 |
| K813644 | MODEL 2650 HIGH CAPACITY DUAL SYRINGE | Harvard Apparatus, Inc. | 1982-02-18 | 49 | 0 |
| K801904 | SYRINGE INFUSION PUMP #2716 | Harvard Apparatus, Inc. | 1980-08-27 | 16 | 0 |
| K800569 | SYRINGE INFUSION PUMP #2720 | Harvard Apparatus, Inc. | 1980-04-08 | 25 | 0 |
| K791293 | BATTERY POWERED SYRINGE INFUSION PUMP | Harvard Apparatus, Inc. | 1979-11-13 | 126 | 0 |
| K780705 | INFUSION PUMP-MODEL 2616 | Harvard Apparatus, Inc. | 1978-05-19 | 24 | 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