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

Covidien, LLC — Predicate Candidate Screening

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

106 daysmedian FDA review time

258 days90th percentile

90clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253527	Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGC	Covidien, LLC	2026-07-01	230	0
K253984	Instrument Exit Point on Touch Surgery™ Aide	Covidien, LLC	2026-06-04	174	0
K253030	Capnostream™35 Portable Respiratory Monitor (PM35MN)	Covidien, LLC	2026-05-01	224	0
K251025	Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor	Covidien, LLC	2025-12-29	271	0
K251313	Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard	Covidien, LLC	2025-12-29	245	0
K250725	Hugo™ RAS System	Covidien, LLC	2025-12-03	268	0
K250173	Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX)	Covidien, LLC	2025-10-06	258	0
K243785	Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinf	Covidien, LLC	2025-09-25	290	0
K241085	Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10	Covidien, LLC	2024-07-12	84	0
K240572	Valleylab™ SM Smoke Management Pencil with Edge™ Blade Elect	Covidien, LLC	2024-07-01	123	0
K233341	Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-	Covidien, LLC	2024-05-20	234	0
K230693	BIS™ Advance Monitoring System	Covidien, LLC	2024-02-26	350	0
K231861	EndoflipTM 300 System	Covidien, LLC	2023-07-21	28	0
K223705	EndoflipTM 300	Covidien, LLC	2023-04-14	123	0
K223158	LigaSure™ XP Maryland Jaw Sealer/Divider	Covidien, LLC	2023-01-23	108	0
K213911	Microstream CO2 NanoPod	Covidien, LLC	2022-07-29	226	0
DEN220006	ProdiGI	Covidien, LLC	2022-06-13	150	0
K212555	Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellco	Covidien, LLC	2022-05-06	266	0
K213518	CARESCAPE CO2 Microstream parameter	Covidien, LLC	2022-04-12	160	0
K203150	Cool-tip RF Ablation System E Series	Covidien, LLC	2022-02-25	491	0
K213602	Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritonea	Covidien, LLC	2022-01-14	60	0
K211561	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, I	Covidien, LLC	2021-12-05	199	1
K212301	Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Devic	Covidien, LLC	2021-11-15	115	0
K210338	Edge Insulated Blade Electrode	Covidien, LLC	2021-04-15	69	0
K202917	LigaSure Exact Dissector, Nano-coated	Covidien, LLC	2021-03-23	175	0
K202874	Puritan Bennett Cuff Pressure Manager	Covidien, LLC	2021-01-09	103	1
K203303	Emprint SX Ablation Platform with Thermosphere Technology	Covidien, LLC	2020-12-17	38	0
K193056	Puritan Bennett 980 Series Ventilator System	Covidien, LLC	2020-11-20	385	17
K200796	Emprint Ablation System with Thermosphere Technology	Covidien, LLC	2020-08-26	153	0
K201179	GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nel	Covidien, LLC	2020-07-20	80	0
K200427	Sonicision Cordless Ultrasonic Dissector	Covidien, LLC	2020-07-10	140	0
K200146	HET Bipolar Electrocautery Forceps, HET Bipolar Electrocaute	Covidien, LLC	2020-05-07	106	0
K193356	BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/D	Covidien, LLC	2020-03-02	89	0
K193232	Emprint Ablation System with Thermosphere Technology, Emprin	Covidien, LLC	2020-02-13	80	0
K192302	Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lu	Covidien, LLC	2020-01-17	147	6
K192038	Emprint Visualization Application	Covidien, LLC	2019-12-02	125	0
K191394	ILLUMISITE Platform	Covidien, LLC	2019-08-07	75	1
K182868	INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor	Covidien, LLC	2019-01-08	88	1
K182451	BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/D	Covidien, LLC	2018-11-06	60	0
K181020	Cytosponge Cell Collection Device	Covidien, LLC	2018-08-16	121	1
K180485	Argyle Peritoneal Dialysis Catheter and Kits, Argyle Prester	Covidien, LLC	2018-07-27	154	0
K180037	Beacon EUS Access System	Covidien, LLC	2018-04-26	111	2
K180149	Sonicision Reusable Generator, Sonicision Reusable Battery P	Covidien, LLC	2018-03-26	66	0
K180192	Emprint Ablation Visualization Application	Covidien, LLC	2018-03-21	56	0
K173244	superDimension Navigation System V7.2	Covidien, LLC	2018-02-08	125	0
K173559	Barrx SB RFA Endoscopic Catheter	Covidien, LLC	2018-01-18	62	0
K172757	Valleylab FX8 Electrosurgical Platform	Covidien, LLC	2017-11-02	50	0
K171066	BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/D	Covidien, LLC	2017-06-08	59	0
K163537	Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle	Covidien, LLC	2017-04-21	126	0
K163654	VersaOne fascial closure system bladed trocar, VersaOne fasc	Covidien, LLC	2017-03-08	75	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