Atlas FDA

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

Kemble Instruments, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time
71 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K842894KEMBLE 405Kemble Instruments, Inc.1984-08-27350
K832760RIA SOFTWAREKemble Instruments, Inc.1983-10-14560
K832734KEMTEK 400 RIA GAMMA COUNTERKemble Instruments, Inc.1983-10-14710
K832736KEMTEK 104 RIA GAMMA COUNTERKemble Instruments, Inc.1983-09-29520
K832735KEMTEK 103 RIA GAMMA COUNTERKemble Instruments, Inc.1983-09-29560
K830751KEMTEK 102Kemble Instruments, Inc.1983-04-06270
K822293IMMU-COUNT 404Kemble Instruments, Inc.1982-08-24220
K827748THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBEKemble Instruments, Inc.1982-08-16270
K820137IMMU-COUNTKemble Instruments, Inc.1982-02-05180

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