Atlas FDA

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

Abbott — Predicate Candidate Screening

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

113 daysmedian FDA review time
151 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CAbbott2026-07-02300
K260993Amplatzer TorqVue Delivery SystemAbbott2026-04-24290
K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Abbott2025-09-171490
K233655Lingo Glucose SystemAbbott2024-05-291970
K222297CentriMag Pre-connected PackAbbott2022-12-011220
K221213EnSite X EP SystemAbbott2022-08-181130
K212061EnSite X EP SystemAbbott2021-10-221130
K210392WorkMate Claris SystemAbbott2021-03-11290
K192593Confirm Rx Insertable Cardiac MonitorAbbott2019-10-18280
K190167MitraClip G4 Steerable Guide CatheterAbbott2019-05-291180
K182981Confirm Rx Insertable Cardiac MonitorAbbott2019-03-291510
K183128EnSite Velocity Cardiac Mapping System v5.2, EnSite PrecisioAbbott2018-12-12290
K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite PrecisioAbbott2018-10-19250

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