Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Tyco Healthcare · Predicate Candidate Screening

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

110 daysmedian FDA review time
187 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071049DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSORTyco Healthcare2007-10-161860
K070685KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662Tyco Healthcare2007-09-141860
K070653KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC UTyco Healthcare2007-09-121870
K061492MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGETyco Healthcare2006-08-03640
K042709DOVER SILVER TEMPERATURE SENSING FOLEY CATHETERTyco Healthcare2005-01-181100
K040897DOVER ROB-NEL CATHETERTyco Healthcare2004-07-201050
K040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVETyco Healthcare2004-07-151260
K041243DOVER RED RUBBER ROBINSON CATHETERTyco Healthcare2004-07-07570
K032438MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH Tyco Healthcare2004-06-3032822
K033453KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSINGTyco Healthcare2004-04-291820
K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco Healthcare2003-12-08890
K033373MONOJECT INSULIN SYRINGETyco Healthcare2003-11-13221
K013556MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGETyco Healthcare2001-12-31670
K012736MONOJECT SAFETY NEEDLETyco Healthcare2001-10-257092

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