Atlas FDA

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

LXP — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

96 daysmedian FDA review time
265 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K022186SCLERAL PLUGS, 19 AND 20 GAUGEMicrovision, Inc.2003-02-262360
K990872SCLERAL PLUGS, 19 AND 20 GAUGEOphthalmic Consultants, Inc.1999-07-131190
K945114VISITEC SCLERAL PLUGVisitec Co.1995-02-231280
K925671DISPOSABLE SCLERAL PLUGSO.R. Specialties, Inc.1993-08-022650
K880952PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, Inc.1988-05-13670
K880953ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUGAdvanced Surgical Products, Inc.1988-05-13670
K871604MVS 19 AND MVS 20 GAUGE SCLERAL PLUGSAdvanced Surgical Products, Inc.1987-06-12490
K854507STORZ MVS 19 & 20 GAUGE SCLERAL PLUGSStorz Instrument Co.1986-02-07870
K840693DISPOSABLE SCLERAL GLOBE PLUGInnovative Surgical Products, Inc.1984-05-22960
K831193SCLERAL PLUGMedical Instrument Development Laboratories, Inc.1983-06-30790

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