# Etiometry, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 11 (2015–2026): 11 510(k) clearances
- Product codes: MWI (5), PPW (4), PLB (2)
- 510(k) review time since 2016: median 205 days, against 205 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 19 (12 its own); citations of its devices by later devices: 13 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Obs Medical: 2 (https://510kreport.com/company/obs-medical)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Flashback Technologies, Inc.: 1 (https://510kreport.com/company/flashback-technologies)
- Covidien, Formerly Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/covidien-formerly-nellcor-puritan-bennett)
- Somanetics Corp.: 1 (https://510kreport.com/company/somanetics)

## Firms that cite its devices most
- Ultromics Limited: 1 (https://510kreport.com/company/ultromics)

## Its most-cited devices
- K213230: T3 Platform Software (2022), cited by 3
- K142732: T3 Software (2015), cited by 2
- K163065: T3 Software (2017), cited by 1
- K152258: T3 Software (2016), cited by 1
- K223578: T3 Platform software (2023), cited by 1
- K151715: T3 Software (2015), cited by 1

## Recent decisions
- K254066: Etiometry Platform (Apr 3, 2026)
- K241479: Etiometry Platform (DAV 5.4 RAE 9.2) (Feb 12, 2025)
- K223578: T3 Platform software (Jul 7, 2023)
- K213423: T3 Platform software (Jan 6, 2023)
- K213230: T3 Platform Software (Jun 22, 2022)
- K202306: T3 Platform software (Nov 25, 2020)
- K190273: T3 Platform software (Dec 8, 2019)
- K163065: T3 Software (May 26, 2017)

Source page: https://510kreport.com/company/etiometry