What is the FDA recognition number for IEEE 11073-10419?

13-145: IEEE Std 11073-10419:2023. 13-81: IEEE Std 11073-10419:2015.

FDA-recognized standard · Software/Informatics

IEEE 11073-10419: Health informatics - Device Interoperability Part 10419: Personal health device communication - Device Specialization - Insulin Pump

Yes. FDA recognizes IEEE Std 11073-10419:2023 as recognition 13-145, entered 2025-05-26. FDA also lists IEEE Std 11073-10419:2015 (recognition 13-81, transition period ending 2027-07-04).

Recognized editions of IEEE 11073-10419

FDA recognitions of IEEE 11073-10419, newest first (FDA database snapshot of 2026-09-01)
Recognition	Edition	Entered	Extent	Transition ends
13-145	IEEE Std 11073-10419:2023	2025-05-26	Complete	—
13-81	IEEE Std 11073-10419:2015 also ISO IEEE 11073-10419 First edition 2016-06-15	2016-04-04	Complete	2027-07-04

Regulations

FDA lists these classification regulations against IEEE 11073-10419: 21 CFR 880.5725.

Product codes that cite IEEE 11073-10419

5 FDA product codes cite IEEE 11073-10419, including LZG, OPP, OYC, OZO, OZP.

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.