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Isa or+ 9685

by Masimo Corporation

Isa or+ 9685 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K171121 on 17 Nov 2017 and listed in FDA GUDID since 16 Mar 2022 (UDI-DI 00843997009317), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K171121

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843997009317 UDI-DI Date16 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171121 Date17 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171121 decided 17 Nov 2017 Active
  • FDA GUDID UDI-DI 00843997009317 listed 16 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171121
  2. Listed FDA GUDID 00843997009317

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Isa or+
Generic name
Respiration monitor
Model / reference
9685
Primary DI / UDI-DI
00843997009317
510(k) Number
FDA product code
CCK
GMDN term
Respiration monitor
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Respiration monitor

Cleared under the same submission (K171121)

and 8 more cleared under K171121

Similar devices

Other devices filed under FDA product code CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE).

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (12, all answered No)