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

Oasis Medical, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
234 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugOasis Medical, Inc.2022-06-031650
K162361Soft Plug Extended Duration 180 Canalicular PlugOasis Medical, Inc.2017-04-172370
K032297DISPOSABLE N-PE MICKROKERATOME BLADESOasis Medical, Inc.2003-08-26320
K030401DISPOSABLE M2-PE MICROKERATOME BLADESOasis Medical, Inc.2003-06-191330
K022205DISPOSABLE N-PE MICROKERATOME BLADESOasis Medical, Inc.2002-10-03900
K013613SOFT PLUG ABSORBABLE PLUG-SAOasis Medical, Inc.2002-06-272341
K003820DISPOSABLE CB-PE MICROKERATOME BLADESOasis Medical, Inc.2001-03-08870
K001176DISPOSABLE MICROKERATOME BLADES-PEOasis Medical, Inc.2000-09-211630
K980437SILICONE PUNCTAL PLUGOasis Medical, Inc.1998-04-30850
K950798POSTERIOR CAPSULE SHIELDOasis Medical, Inc.1995-05-22900
K950241OPHTHALMIC SPONGESOasis Medical, Inc.1995-02-27380
K946357COLLAGEN INTRACANALICULAR PLUGOasis Medical, Inc.1995-02-07390
K945906SILICONE PUNCTAL PLUGOasis Medical, Inc.1995-01-03320
K943379PHACO TIPS FOR PHACO FRAGMENTATION MACHINESOasis Medical, Inc.1994-10-11900
K934204INTERTIP INFUSION SETOasis Medical, Inc.1994-02-071610
K923877TONOSHIELD TONOMETER SHIELDOasis Medical, Inc.1992-09-30580
K914529SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSOasis Medical, Inc.1991-11-13330

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