Atlas FDA

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

Tearscience, Inc. — Predicate Candidate Screening

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

106 daysmedian FDA review time
323 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192623LipiFlow Thermal Pulsation SystemTearscience, Inc.2019-10-22290
K182506LipiScan Dynamic Meibomian ImagerTearscience, Inc.2018-12-10890
K161357LipiFlow Thermal Pulsation SystemTearscience, Inc.2016-11-041721
K152869LipiView II Ocular Surface InterferometerTearscience, Inc.2016-01-141060
K133127LIPIFLOW THERMAL PULSATION SYSTEMTearscience, Inc.2013-12-23842
K122481LIPIVIEW OCULAR SURFACE INTERFEROMETERTearscience, Inc.2012-12-311390
K112704LIPIFLOW THERMAL PULSATION SYSTEMTearscience, Inc.2011-12-19942
DEN100017LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTETearscience, Inc.2011-06-283230
K091935LIPIVIEW OCULAR SURFACE INTERFEROMETERTearscience, Inc.2009-10-231150

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