Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kells Medical, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

78 daysmedian FDA review time
211 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K926333CPR PLUSKells Medical, Inc.1993-11-083270
K890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETKells Medical, Inc.1989-07-241950
K890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETKells Medical, Inc.1989-05-241340
K890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETKells Medical, Inc.1989-05-241340
K861972DERMISTRIPKells Medical, Inc.1986-06-27370
K844463DERMIDRESSKells Medical, Inc.1985-01-08490
K844072DERMIZIP SKIN CLOSURE DEVICEKells Medical, Inc.1984-11-05180
K832678PHONATORY FUNCTION ANALYZER PS-77Kells Medical, Inc.1984-03-072110
K832667LUCAE'S EAR & NASAL APPLICATORSKells Medical, Inc.1983-09-29510
K823118SAYKells Medical, Inc.1983-01-07780
K823226SN-100 DOCTOR'S ROUNDKells Medical, Inc.1982-11-22240
K823227IMPEDANCE METER ON-1Kells Medical, Inc.1982-11-22240

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