FDA-recognized standard · Anesthesiology
ISO 10079-4: Medical suction equipment - Part 4: General requirements
Yes. FDA recognizes ISO 10079-4 First edition 2021-08 as recognition 1-158, entered 2022-12-19.
Recognized editions of ISO 10079-4
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 1-158 | ISO 10079-4 First edition 2021-08 | 2022-12-19 | Complete | — |
Regulations
FDA lists these classification regulations against ISO 10079-4: 21 CFR 870.5050, 21 CFR 870.5910, 21 CFR 874.5350, 21 CFR 876.1500, 21 CFR 878.4680, 21 CFR 878.4683, 21 CFR 878.4780, 21 CFR 878.5040, 21 CFR 880.6740.
Product codes that cite ISO 10079-4
13 FDA product codes cite ISO 10079-4, including BTA, DWM, EWT, GCY, JCX.
- BTA Pump, Portable, Aspiration (Manual Or Powered)
- DWM
- EWT
- GCY
- JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
- KDP
- MUU System, Suction, Lipoplasty
- OCX Endoscopic Irrigation/Suction System
- 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.