Atlas FDA

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

Kleen Test Products — Predicate Candidate Screening

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

23 daysmedian FDA review time
81 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890039KLEEN TEST BASIN SETKleen Test Products1989-10-242870
K890539SURE COUNT LIGHT HANDLE COVERKleen Test Products1989-02-27240
K890098KLEEN TEST O.R. KITKleen Test Products1989-01-24140
K853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030Kleen Test Products1985-10-10420
K853454SURE COUNT 5 & 10 SPONGE COUNTERKleen Test Products1985-09-05200
K853315CAUTERY TIP CLEANING PADKleen Test Products1985-08-21140
K852258SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTERKleen Test Products1985-06-27340
K852257SURE-COUNT 15 COUNT NEEDLE COUNTERKleen Test Products1985-06-26330
K844199ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINETKleen Test Products1984-11-0780
K821396OUT-RITE WASTE DISPOSABLE BAGKleen Test Products1982-06-09290
K821395SADDLEBAG INSTRUMENT PAD W/POUCHESKleen Test Products1982-06-03230
K821394SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTERKleen Test Products1982-06-03230
K801259NEEDLE COUNTER-SURE COUNT/100 COUNTKleen Test Products1980-06-09120
K801256NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAYKleen Test Products1980-06-0470
K801257NEEDLE COUNTER-SURE COUNT/30 CT. MAGN.Kleen Test Products1980-06-0470
K801258NEEDLE COUNTER-SURE COUNT/10 COUNTKleen Test Products1980-06-0470
K760428SUTURE RACK & NEEDLE COUNTERKleen Test Products1976-11-02810

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