510(k) Report

FDA product code · Clinical chemistry

Osmolality Of Tears

ONDClass I21 CFR 862.1540510(k) exempt1 decision since 20090 recalls

FDA lists OND as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2009. No recall names this code. The most-cited predicate is K083184, named by 1 later device.

To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, clinical chemistry panel

Twenty years of OND at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OND

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code OND, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OND by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OND? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OND devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K083184Tearlab Osmolarity SystemOcusense, Inc. · 20091cites it

Which OND devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K083184Tearlab Osmolarity SystemOcusense, Inc. · 20093generations

What has FDA decided in OND lately?

  • K083184Tearlab Osmolarity SystemOcusense, Inc. · 2009

The one OND decision →

Related product codes

Other codes under 21 CFR 862.1540.

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