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

Abbott Medical — Predicate Candidate Screening

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

85 daysmedian FDA review time

186 days90th percentile

59clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K262006	EnSite™ X EP System	Abbott Medical	2026-07-15	30	0
K261631	Amplatzer TorqVue Exchange System	Abbott Medical	2026-06-17	30	0
K253459	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated	ABBOTT MEDICAL	2026-04-24	199	0
K260212	EnSite™ X EP System	ABBOTT MEDICAL	2026-04-20	87	0
K253907	Disposable Radiofrequency Cannula	ABBOTT MEDICAL	2026-04-16	132	0
K260499	Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F	ABBOTT MEDICAL	2026-03-13	28	0
K252512	Armada™ 14 NC PTA Catheter	ABBOTT MEDICAL	2026-02-13	186	0
K253516	Assert-IQ (DM5100)	ABBOTT MEDICAL	2025-12-18	36	0
K252417	Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)	ABBOTT MEDICAL	2025-12-17	138	0
K253232	Seguin Annuloplasty Ring	ABBOTT MEDICAL	2025-10-29	30	0
K250031	Amplatzer Guidewire	ABBOTT MEDICAL	2025-10-03	269	0
K252013	EnSite™ X EP System	ABBOTT MEDICAL	2025-09-25	90	0
K251463	EnSite™ X EP System, AutoMark Index Software License (ENSITE	ABBOTT MEDICAL	2025-09-04	115	0
K251234	EnSite™ X EP System	ABBOTT MEDICAL	2025-07-30	99	0
K250552	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14	ABBOTT MEDICAL	2025-07-25	150	0
K242841	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	ABBOTT MEDICAL	2025-05-27	250	0
K251211	ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE C	ABBOTT MEDICAL	2025-05-23	35	0
K251231	ViewFlex™ X ICE Catheter, Sensor Enabled™	ABBOTT MEDICAL	2025-05-20	28	0
K250426	Amulet™ Steerable Delivery Sheath	ABBOTT MEDICAL	2025-04-25	70	0
K243549	JETi Hydrodynamic Thrombectomy System	ABBOTT MEDICAL	2025-04-04	140	0
K243224	MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G	ABBOTT MEDICAL	2024-12-31	85	0
K243493	Agilis NxT Steerable Introducer Dual-Reach	ABBOTT MEDICAL	2024-12-13	31	0
K240997	Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14	ABBOTT MEDICAL	2024-11-06	209	0
K241538	TriClip Steerable Guide Catheter	ABBOTT MEDICAL	2024-08-26	88	0
K242016	EnSite™ X EP System	ABBOTT MEDICAL	2024-08-09	30	0
K241372	Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™	ABBOTT MEDICAL	2024-07-09	55	0
K241370	Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)	ABBOTT MEDICAL	2024-06-13	30	0
K234118	CentriMag™ Acute Circulatory Support System	ABBOTT MEDICAL	2024-01-26	29	0
K232458	JETi™Hydrodynamic Thrombectomy System	ABBOTT MEDICAL	2023-12-19	126	0
K232690	Amulet™ Steerable Delivery Sheath	ABBOTT MEDICAL	2023-09-29	28	0
K232386	ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mob	ABBOTT MEDICAL	2023-09-08	30	0
K231415	EnSite™ X EP System	ABBOTT MEDICAL	2023-08-10	86	0
K231588	ViewFlex™ Eco Reprocessed ICE Catheter	ABBOTT MEDICAL	2023-06-30	29	0
K231311	CPS Direct™ Universal slittable outer guide catheter (DS2C02	ABBOTT MEDICAL	2023-06-02	28	0
K230286	Assert-IQ™ Insertable Cardiac Monitor	ABBOTT MEDICAL	2023-05-17	104	0
K230934	ViewFlex™ Eco Reprocessed ICE Catheter	ABBOTT MEDICAL	2023-05-03	30	0
K230411	Dragonfly OpStar™ Imaging Catheter	ABBOTT MEDICAL	2023-04-14	58	0
K230283	Peel-Away Introducer (405104, 405108, 405112, 405116, 405118	ABBOTT MEDICAL	2023-03-01	28	0
K223094	EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Ena	ABBOTT MEDICAL	2022-12-27	88	0
K222217	ViewFlex Xtra Reprocessed ICE Catheter	ABBOTT MEDICAL	2022-12-19	147	0
K221397	MitraClip G4 Steerable Guide Catheter	ABBOTT MEDICAL	2022-09-28	138	0
K221750	CPS AIM Universal II Slittable Inner Catheter	ABBOTT MEDICAL	2022-06-30	14	0
K220243	Ultiri Measurement System	ABBOTT MEDICAL	2022-04-30	92	0
K213494	Aveir Retrieval Catheter	ABBOTT MEDICAL	2022-04-01	151	0
K220340	Amplatzer Steerable Delivery Sheath	ABBOTT MEDICAL	2022-03-09	30	1
K203293	Abbott Medical Grounding Pad, model RF-DGP-IS	ABBOTT MEDICAL	2022-01-21	438	0
K213364	EnSite X EP System	ABBOTT MEDICAL	2021-11-11	30	0
K212738	Amplatzer Talisman Delivery Sheath	ABBOTT MEDICAL	2021-09-27	28	0
K212026	Amplatzer Steerable Delivery Sheath	ABBOTT MEDICAL	2021-09-27	90	0
K211989	Aveir Introducer	ABBOTT MEDICAL	2021-07-27	29	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