# K083184: Tearlab Osmolarity System

- Pathway: 510(k) (Traditional)
- Applicant: Ocusense, Inc.
- Decided: May 14, 2009 after 198 days
- Product code: OND (Osmolality Of Tears)
- Device class: 1
- Regulation: 21 CFR 862.1540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940043 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991316: Touch Tear Ige Microassay Kit, Touch Scientific, Inc. (1999) Summary page 1.
- K971976: Diascreen Reagent Strips, Dia-Screen Corp. (1997) Summary page 1.
- (no number) Wescor, Inc., 5520 Vapro® Vapor Pressure Osmometer: named in the summary without a submission number
- (no number) Alcon Laboratories, Inc., Schirmer Tear Test: named in the summary without a submission number

## Most influential descendants
- K132066: Inflamma Dry (2013), 0 descendants of its own

## Indications for use
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of dry eye disease in patients suspected of having dry eye disease, in conjunction with other methods of clinical evaluation.

Source page: https://510kreport.com/device/K083184
Methodology: https://510kreport.com/methodology