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

Covidien — Predicate Candidate Screening

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

106 daysmedian FDA review time

244 days90th percentile

130clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K241486	Sofsilk™ Coated Braided Silk Suture	Covidien	2024-12-03	193	0
K240077	Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050,	Covidien	2024-08-20	223	0
K231934	GIA™ Stapler with Tri-Staple™ Technology	Covidien	2023-10-27	119	0
K231240	MaxTack™ Motorized Fixation Device	Covidien	2023-09-08	133	0
K223130	Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGua	Covidien	2023-08-30	331	0
K231491	TA™ Stapler and Loading Unit with DST Series™ Technology	Covidien	2023-08-16	85	0
K232126	EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™	Covidien	2023-08-16	30	0
K221629	Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™	Covidien	2023-02-22	261	0
K221771	EEA Circular Stapler with Tri-Staple Technology	Covidien	2022-11-30	162	0
K222641	Signia™ Small Diameter Reloads Including Regular (Round) Tip	Covidien	2022-11-29	89	1
K221003	Autosuture EEA Stapler / circular stapler with DST Series Te	Covidien	2022-09-30	178	0
K220540	ProGrip Self-Gripping Polypropylene Mesh	Covidien	2022-09-22	209	0
K213818	VersaOne Optical Trocar with Fixation Balloon Cannula, Versa	Covidien	2022-06-27	202	0
K221013	GIA Auto Suture Stapler with DST Series Technology	Covidien	2022-05-05	30	0
K221005	EEA Circular Stapler with Tri-Staple Technology	Covidien	2022-04-29	24	0
K221006	GIA Stapler with Tri-Staple Technology	Covidien	2022-04-29	24	0
K203762	Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor	Covidien	2021-09-17	268	0
K202507	EEA Circular Stapler with Tri-Staple Technology	Covidien	2021-01-21	143	0
K202701	GIA Stapler with Tri-Staple Technology	Covidien	2020-12-07	82	0
K202864	Tri-Staple 2.0 Reloads	Covidien	2020-10-28	30	0
K201805	VersaOne Reusable Positioning Trocar System	Covidien	2020-08-26	56	3
K201672	Signia Stapler (with new software)	Covidien	2020-07-17	28	0
K193077	Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard	Covidien	2020-06-01	209	0
K192720	GIA Stapler with Tri-Staple Technology	Covidien	2020-03-13	168	0
K192330	EEA Circular Stapler with Tri-Staple Technology	Covidien	2020-01-23	149	0
K191070	Signia Small Diameter Reloads	Covidien	2019-09-04	135	4
K191601	Valleylab FT10 Electrosurgical Platform	Covidien	2019-07-12	25	1
K182861	Shiley Neonatal/Pediatric Tracheostomy Tube	Covidien	2019-03-22	162	0
K182475	Signia Circular Adapters (for use with Signia Staplers), Tri	Covidien	2019-03-14	185	0
K182772	Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab	Covidien	2018-11-19	49	0
K180622	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	Covidien	2018-10-23	228	0
K180496	TruClear Elite Hysteroscope	Covidien	2018-08-29	184	0
K180915	Sonicision Reusable Sterilization Tray	Covidien	2018-07-17	99	0
K181085	LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Seali	Covidien	2018-06-21	57	0
K181389	Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Ener	Covidien	2018-06-19	25	0
K173281	LigaSure Exact Dissector, Nano-coated	Covidien	2018-03-02	137	0
K173270	Tri-Staple 2.0 Reinforced Reload	Covidien	2018-02-20	131	1
K172361	EEA Circular Stapler with Tri-Staple Technology	Covidien	2018-02-16	196	0
K172482	The Nellcor pulse oximetry monitor interface cable	Covidien	2017-12-15	121	0
K162738	Puritan Bennett 980 Ventilator System	Covidien	2017-10-27	392	1
K170869	LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-	Covidien	2017-04-21	29	0
K170348	Signia Four-Bay Smart Charger (to be used with Signia Staple	Covidien	2017-03-02	27	0
K163620	Reprocessed Kendall SCD Express Compression Sleeves, Reproce	Covidien	2017-01-19	28	0
K163055	Reprocessed Kendall SCD Express Foot Cuff	Covidien	2016-12-23	52	0
K163102	ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen	Covidien	2016-11-30	23	0
K160718	Vital Sync Informatics Manager & Virtual Patient Monitoring	Covidien	2016-11-14	244	1
K162941	Ligasure Blunt Tip, Sealer/Divider, Nano-coated	Covidien	2016-11-14	24	1
K162584	VersaOne Bladeless Trocar	Covidien	2016-10-18	32	0
K161804	LigaSure Retractable L-Hook Laparoscopic Sealer/Divider	Covidien	2016-09-16	78	0
K162047	LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano	Covidien	2016-09-15	52	0

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