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MightySat 9942

by Masimo Corporation

MightySat 9942 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K181956 on 23 Jan 2019 and listed in FDA GUDID since 3 Sep 2020 (UDI-DI 00843997014465), 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) K181956

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 Number00843997014465 UDI-DI Date3 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181956 Date23 Jan 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181956 decided 23 Jan 2019 Active
  • FDA GUDID UDI-DI 00843997014465 listed 3 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181956
  2. Listed FDA GUDID 00843997014465

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MightySat
Generic name
Pulse oximeter
Model / reference
9942
Primary DI / UDI-DI
00843997014465
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter

Cleared under the same submission (K181956)

and 1 more cleared under K181956

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)