Atlas FDA

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

Teleflex Medical — Predicate Candidate Screening

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

72 daysmedian FDA review time
260 days90th percentile
39clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical2025-07-03900
K242495LMA Fastrach ETT SUTeleflex Medical2025-04-292500
K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical2025-03-181200
K241784Arrow® Nitinol WireTeleflex Medical2024-09-18900
K233713Pilling Tracheostomy TubesTeleflex Medical2024-03-221230
K232970Hem-o-lok® Ligating ClipsTeleflex Medical2024-01-121130
K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); ArrowTeleflex Medical2023-08-301800
K231924EZ-IO Intraosseous Vascular Access SystemTeleflex Medical2023-07-25250
K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05MTeleflex Medical2023-04-28650
K222279Rusch Intermittent Urethral CathetersTeleflex Medical2022-08-29310
K202492EZ-IO Intraosseous Vascular Access SystemTeleflex Medical2021-03-222030
K192490Tevdek II, Silky II Polydek, 'Cottony' II, NextStitchTeleflex Medical2020-03-302010
K193530Deklene MAXXTeleflex Medical2020-03-19900
K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFiTeleflex Medical2019-08-212260
K180253Sheridan Endobronchial TubesTeleflex Medical2018-11-022760
K173321StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StTeleflex Medical2018-04-251870
K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Teleflex Medical2018-04-17420
K173596Rusch Intermittent Urethral CathetersTeleflex Medical2018-01-29690
K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical2016-09-07720
K153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical2016-08-192613
K133202HEM-O-LOK LIGATING CLIPTeleflex Medical2013-12-03470
K132658HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING Teleflex Medical2013-11-27931
K130405RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SETTeleflex Medical2013-11-062600
K112958HUMID-VENT HEPATeleflex Medical2012-09-213520
K100506FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NTeleflex Medical2010-03-10160
K082156ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 405Teleflex Medical2008-09-10425
K070561KMEDIC INTERNAL/EXTERNAL FIXATION DEVICESTeleflex Medical2007-05-25870
K063758CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNETeleflex Medical2007-04-231252
K063778FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURETeleflex Medical2007-02-09501
K062914HEM-O-LOK LIGATION CLIPTeleflex Medical2006-11-02360
K061736COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULATeleflex Medical2006-08-18590
K060801DEKNA-LOK MODEL BP1000V2LTeleflex Medical2006-05-17540
K060519INTRODUCER ASSEMBLY WITH ROTATOR LOCKTeleflex Medical2006-05-05670
K043205RUSCH EASY TUBETeleflex Medical2005-01-07490
K043258MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO.Teleflex Medical2004-12-16220
K042141POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURETeleflex Medical2004-09-28500
K040472FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGITeleflex Medical2004-03-15200
K033654FORCE FIBERTeleflex Medical2004-01-15550
K033115ORTHODEKTeleflex Medical2003-11-17480

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