Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Abbott Mfg., Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
237 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981457 | ALBP | Abbott Mfg., Inc. | 1998-05-27 | 34 | 0 |
| K981232 | CA | Abbott Mfg., Inc. | 1998-05-18 | 45 | 0 |
| K981231 | CO2 | Abbott Mfg., Inc. | 1998-05-12 | 39 | 0 |
| K965230 | ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP | Abbott Mfg., Inc. | 1997-07-03 | 184 | 0 |
| K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | Abbott Mfg., Inc. | 1997-06-27 | 81 | 1 |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-10-03 | 77 | 0 |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-09-25 | 69 | 0 |
| K944669 | FLEXIFLO QUANTUM ENTERAL PUMP | Abbott Mfg., Inc. | 1995-07-24 | 314 | 3 |
| K943691 | IMX FOLATE | Abbott Mfg., Inc. | 1995-03-23 | 237 | 5 |
| K943733 | FLEXIFLO SIX ENTERAL NUTRITION PUMP | Abbott Mfg., Inc. | 1994-12-12 | 132 | 0 |
| K941214 | LIFESHIELD EXTENSION SET | Abbott Mfg., Inc. | 1994-10-03 | 207 | 10 |
| K940289 | ABBOTT PRISM ANALYZER | Abbott Mfg., Inc. | 1994-07-18 | 138 | 0 |
| K935376 | AXSYM GENTAMICIN | Abbott Mfg., Inc. | 1994-06-21 | 225 | 1 |
| K902753 | IMX ULTRASENTITIVE HTSH | Abbott Mfg., Inc. | 1990-07-10 | 18 | 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