510(k) · Cleared
ClearedTearlab Osmolarity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocusense, Inc. · OND Osmolality Of Tears
Cleared on May 14, 2009 as substantially equivalent to K991316 (Touch Scientific, Inc., 1999) and 1 other predicate after a 198-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- May 14, 2009
- Review
- 198 days
- Class
- Class I
- Product code
- OND
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940043 (1994). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940043 Bioscan Reagent StripsBioscan Instruments, Inc. · 1994
- 2 generations backK961375 Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996
- 1 generation backK971976 Diascreen Reagent StripsDia-Screen Corp. · 1997
- This deviceK083184 Tearlab Osmolarity SystemOcusense, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK132066 Inflamma DryRapid Pathogen Screening, Inc. · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K132066Inflamma DryRapid Pathogen Screening, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940043 | Bioscan Reagent Strips | Bioscan Instruments, Inc. | 1994 | — |
| −2 | K961375 | Dia Screen 10 Way Reagent Strips | Genesis Labs, Inc. | 1996 | — |
| −1 | K971976 | Diascreen Reagent Strips | Dia-Screen Corp. | 1997 | — |
| 0 (this device) | K083184 | Tearlab Osmolarity System | Ocusense, Inc. | 2009 | — |
| +1 | K132066 | Inflamma Dry | Rapid Pathogen Screening, Inc. | 2013 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OND? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991316 | Touch Tear Ige Microassay KitSummary page 1…es, Inc., Schirmer Tear Test (Class I,Exempt) 3)Touch Scientific, Inc., Touch Tear IgE Microassay Kit (Class II,K991316) 4) Dia-Screen Corp., Diascreen Reagent Strips (Class I,Non-exempt, K97… | 1999 |
| * | K971976 | Diascreen Reagent StripsSummary page 1…h Tear IgE Microassay Kit (Class II,K991316) 4) Dia-Screen Corp., Diascreen Reagent Strips (Class I,Non-exempt, K971976) Intended Use & Indications for Use:… | 1997 |
| * | — | Wescor, Inc., 5520 Vapro® Vapor Pressure Osmometer Named without a submission number | |
| * | — | Alcon Laboratories, Inc., Schirmer Tear Test Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132066 | Inflamma Dry | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K132066 (Rapid Pathogen Screening, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OND devicesOND Osmolality Of Tears: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OND
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · OND
Too few OND 510(k)s in any year since 2007 to give a median.
Recalls per year · OND
No recall names OND since 2007.
Adverse event reports per year · OND
1in 2015
MAUDE reports naming product code OND, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083184: Tearlab Osmolarity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083184
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026