Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Keller Medical Specialties Products, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
162 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990648 | KELLER VITAL SIGNS MONITOR, KMS 890+ | Keller Medical Specialties Products, Inc. | 1999-08-10 | 162 | 0 |
| K982331 | KELLER PULSE OXIMETER, MODEL 850+ | Keller Medical Specialties Products, Inc. | 1998-09-11 | 71 | 0 |
| K914576 | KELLER CARDIAC MONITOR MEDIL KMS870 | Keller Medical Specialties Products, Inc. | 1991-12-30 | 76 | 0 |
| K910262 | KELLER VITAL SIGNS MONITOR - KMS-890 | Keller Medical Specialties Products, Inc. | 1991-04-01 | 69 | 0 |
| K903437 | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | Keller Medical Specialties Products, Inc. | 1990-11-16 | 108 | 0 |
| K895987 | KELLER PULSE OXIMETER - KMS 850 | Keller Medical Specialties Products, Inc. | 1990-02-22 | 133 | 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