Atlas FDA

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

Arstasis, Inc. — Predicate Candidate Screening

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

63 daysmedian FDA review time
183 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151877MicroTract Access SystemArstasis, Inc.2015-08-07290
K140871AXERA 2 ACCESS SYSTEMArstasis, Inc.2014-06-06630
K140287AXERA RX ACCESS SYSTEMArstasis, Inc.2014-05-161000
K140201AXERA 2 ACCESS SYSTEMArstasis, Inc.2014-03-28600
K132263AXERA 2 ACCESS SYSTEMArstasis, Inc.2013-08-19280
K123618AXERA 2 ACCESS SYSTEMArstasis, Inc.2013-03-241210
K123135AXERA 2 ACCESS SYSTEM MODEL AXE200Arstasis, Inc.2013-01-281150
K121521AXERA ACCESS SYSTEMArstasis, Inc.2012-06-21290
K113110AXERA ACCESS SYSTEMArstasis, Inc.2011-11-09200
K103421ARSTASIS DILATOR ADAPTERArstasis, Inc.2011-05-241830
K103143ARSTASIS ONE LATCHWIRE ACCESS SYSTEMArstasis, Inc.2011-02-021000
K102728ARSTASIS ACCESS SYSTEMArstasis, Inc.2010-10-07151
K100615ARSTASIS ACCESS SYSTEMArstasis, Inc.2010-03-30261
K091006ITG VASCULAR ACCESS SYSTEM, MODEL 300Arstasis, Inc.2010-02-253231

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