Atlas FDA

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

Apl Medical Supplies · Predicate Candidate Screening

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

18 daysmedian FDA review time
18 days90th percentile
25clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853617APL SIMMONS CITRATE AGARApl Medical Supplies1985-09-16180
K853618APL SIM MEDIUMApl Medical Supplies1985-09-16180
K853610APL MOTILITY INDOLE ORNITHINE AGARApl Medical Supplies1985-09-16180
K853619APL TRIPLE SUGAR IRON AGARApl Medical Supplies1985-09-16180
K853609APL TRYPTIC SOY BROTHApl Medical Supplies1985-09-12140
K853611APL XYLOSE LYSINE DEOXYCHOLATE AGARApl Medical Supplies1985-09-12140
K853615APL BILE ESCULIN/AZIDE AGARApl Medical Supplies1985-09-0680
K853613APL GN BROTHApl Medical Supplies1985-09-0680
K853616APL CHLAMYDOSPORE AGARApl Medical Supplies1985-09-0680
K853612APL DNASE TEST AGARApl Medical Supplies1985-09-0680
K853614APL FLUID THIOGLYCOLLATE MEDIUMApl Medical Supplies1985-09-0680
K853233APL CHOCOLATE AGARApl Medical Supplies1985-08-19180
K853227APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)Apl Medical Supplies1985-08-19180
K853226APL BIGGY AGAR(NICKERSON)Apl Medical Supplies1985-08-19180
K853235APL HEKTOEN ENTERIC AGARApl Medical Supplies1985-08-19180
K853236APL TSA WITH 5% SHEEP BLOODApl Medical Supplies1985-08-19180
K853229APL 6.5% SODIUM CHLORIDE BROTHApl Medical Supplies1985-08-19180
K853238APL MUELLER HINTON AGARApl Medical Supplies1985-08-19180
K853234APL MACCONKEY AGARApl Medical Supplies1985-08-19180
K853231APL SABOURAUD DEXTROSE AGARApl Medical Supplies1985-08-19180
K853232APL MANNITOL SALT AGARApl Medical Supplies1985-08-19180
K853225APL LEVINE EMB AGARApl Medical Supplies1985-08-19180
K853228APL SALMONELLA-SHIGELLA AGARApl Medical Supplies1985-08-19180
K853237APL MARTIN LEWIS MEDIUMApl Medical Supplies1985-08-19180
K853230APL MYCOBIOTIC AGARApl Medical Supplies1985-08-19180

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