Atlas FDA

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

Kendall Healthcare Products Co. Div.Of Tyco Health · Predicate Candidate Screening

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

81 daysmedian FDA review time
196 days90th percentile
66clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973763KENDALL CURITY IODOFORM PACKING STRIPKendall Healthcare Products Co. Div.Of Tyco Health1997-12-31900
K973511KENDALL CURITY PETROLATUM GAUZEKendall Healthcare Products Co. Div.Of Tyco Health1997-12-16900
K973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,63Kendall Healthcare Products Co. Div.Of Tyco Health1997-12-15900
K973619KENDALL CURITY NON-ADHERING DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1997-12-10780
K973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1997-12-04790
K973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETERKendall Healthcare Products Co. Div.Of Tyco Health1997-11-07500
K970266KENDALL HYDROPHILIC POWDER WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1997-04-23900
K963446KENDALL DUAL LUMEN CATHETERKendall Healthcare Products Co. Div.Of Tyco Health1997-03-181960
K964899KENDALL CURITY URETERAL CATHETERKendall Healthcare Products Co. Div.Of Tyco Health1997-02-07660
K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health1996-12-20380
K961977KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBEKendall Healthcare Products Co. Div.Of Tyco Health1996-07-31722
K954706KENDALL BLUNT TUOHY EPIDURAL NEEDLEKendall Healthcare Products Co. Div.Of Tyco Health1996-05-302310
K953766KENDALL SAFETAP SPINAL ANESTHESIA TRAYKendall Healthcare Products Co. Div.Of Tyco Health1995-11-241020
K953511KENDALL SHERIDAN CPAP SYSTEMKendall Healthcare Products Co. Div.Of Tyco Health1995-10-26920
K950775CURASORB ZN ALGINATE WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1995-04-03410
K950412CURAGEL HYDROGEL WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1995-03-24520
K945675PREPPIES SKIN BARRIER WIPEKendall Healthcare Products Co. Div.Of Tyco Health1995-02-07810
K946269CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRKendall Healthcare Products Co. Div.Of Tyco Health1995-01-12200
K944468KERLIX ZINC SALINE DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1994-11-29810
K944236NEEDLELESS URINE SAMPLING PORTKendall Healthcare Products Co. Div.Of Tyco Health1994-11-16760
K943636CURADERM ALGINATE HYDROCOLLOIDKendall Healthcare Products Co. Div.Of Tyco Health1994-10-03680
K944251KENDALL MODU-VAC CLOSED SUCTION SYSTEMKendall Healthcare Products Co. Div.Of Tyco Health1994-09-21210
K943073CURAFIL WOUND GEL DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1994-07-26280
K942459CURASALT HYPERTONIC SALINE DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1994-06-27340
K941493KENDALL SAFETRAK COMBINED EPIDURAL/SPINAL KITKendall Healthcare Products Co. Div.Of Tyco Health1994-06-22860
K940574TENDERBREDE(R) PACKING AND DEBRIDEMENT SPONGEKendall Healthcare Products Co. Div.Of Tyco Health1994-04-20710
K935774CURITY FAST-CATH FEMALE CATHETER KITKendall Healthcare Products Co. Div.Of Tyco Health1994-04-111290
K933689MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESKendall Healthcare Products Co. Div.Of Tyco Health1993-12-131370
K933400KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SEKendall Healthcare Products Co. Div.Of Tyco Health1993-11-151260
K933399KENDALL URODYNAMIC CATHETERSKendall Healthcare Products Co. Div.Of Tyco Health1993-11-021130
K933259SCD(R) CONTROLLERKendall Healthcare Products Co. Div.Of Tyco Health1993-09-13690
K932835KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICEKendall Healthcare Products Co. Div.Of Tyco Health1993-08-06570
K931459KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBERKendall Healthcare Products Co. Div.Of Tyco Health1993-06-14830
K925417KENDALL HOME RX THERAPEUTIC STOCKINGKendall Healthcare Products Co. Div.Of Tyco Health1993-06-042200
K930551KENDALL UNIVERSAL EXTENSION SETKendall Healthcare Products Co. Div.Of Tyco Health1993-05-12980
K930219KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHEKendall Healthcare Products Co. Div.Of Tyco Health1993-04-271020
K922162CURITY PLASTIC LOSS OF RESISTANCE SYRINGEKendall Healthcare Products Co. Div.Of Tyco Health1993-04-073350
K925805KENDALL WOUND DRAINAGE SYSTEMS-TROCARSKendall Healthcare Products Co. Div.Of Tyco Health1993-02-261020
K925989KENDALL TRU-CLOSE INFECTION CONTROL EVACUATORKendall Healthcare Products Co. Div.Of Tyco Health1993-02-26930
K925749KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 MLKendall Healthcare Products Co. Div.Of Tyco Health1993-02-01800
K921288CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLEKendall Healthcare Products Co. Div.Of Tyco Health1993-01-273160
K925748KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAINKendall Healthcare Products Co. Div.Of Tyco Health1993-01-13610
K925001CURITY CALCIUM ALGINATE WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health1993-01-111010
K922113KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATHKendall Healthcare Products Co. Div.Of Tyco Health1992-12-032120
K921054KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH.Kendall Healthcare Products Co. Div.Of Tyco Health1992-09-232020
K921055KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTERKendall Healthcare Products Co. Div.Of Tyco Health1992-05-11670
K920252CURAD KID SIZE INSTANT COLD PACKKendall Healthcare Products Co. Div.Of Tyco Health1992-02-11210
K915635CURITY VENTED DRESSING SYSTEMKendall Healthcare Products Co. Div.Of Tyco Health1992-01-31450
K910791CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WINGKendall Healthcare Products Co. Div.Of Tyco Health1991-05-17810
K911242KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETERKendall Healthcare Products Co. Div.Of Tyco Health1991-04-25350

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