FDA-recognized standard · Anesthesiology
ISO 10079-1: Medical suction equipment - Part 1: Electrically powered suction equipment [Including Amendment 1 (2026)]
Yes. FDA recognizes ISO 10079-1 Fourth edition 2022-03 [Including AMD1:2026] as recognition 1-203, entered 2026-05-25. FDA also lists ISO 10079-1 Fourth edition 2022-03 (recognition 1-157, transition period ending 2028-07-02).
Recognized editions of ISO 10079-1
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-203 | ISO 10079-1 Fourth edition 2022-03 [Including AMD1:2026] | 2026-05-25 | Complete | — |
| 1-157 | ISO 10079-1 Fourth edition 2022-03 | 2022-12-19 | Complete | 2028-07-02 |
Regulations
FDA lists these classification regulations against ISO 10079-1: 21 CFR 868.1040, 21 CFR 870.5050, 21 CFR 870.5910, 21 CFR 874.5350, 21 CFR 878.4683, 21 CFR 878.4780, 21 CFR 878.5040.
Product codes that cite ISO 10079-1
11 FDA product codes cite ISO 10079-1, including BSI, BTA, DWM, EWT, JCX.
- BSI
- BTA Pump, Portable, Aspiration (Manual Or Powered)
- DWM
- EWT
- JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
- MUU System, Suction, Lipoplasty
- OKO
- OMP Negative Pressure Wound Therapy Powered Suction Pump
- OTK
- PLA
- QPB System, Suction, Lipoplasty For Removal
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.