Atlas FDA

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

Permeable Technologies, Inc. — Predicate Candidate Screening

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

110 daysmedian FDA review time
221 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963001LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LPermeable Technologies, Inc.1997-03-112210
K963011LIFESTYLE FREQUENCY PROGRESSIVE (METHAFILCON A) MULTIFOCAL HPermeable Technologies, Inc.1996-11-291190
K963010LIFESTYLE GP (TELEFOCON B) RIGID GAS PERMEABLE MULTIFOCAL COPermeable Technologies, Inc.1996-11-201100
K951893LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLPermeable Technologies, Inc.1995-11-172070
K945981LIFESTYLE 55 (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSPermeable Technologies, Inc.1995-02-07610
K950283LIFESTYLE 4-VUE(TM) (POLYMACON) HYDROPHILIC CONTACT LENSPermeable Technologies, Inc.1995-02-07140
K942494LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LEPermeable Technologies, Inc.1994-09-081060

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