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Perifit Pump 18mm

by X6 Innovations

Perifit Pump 18mm is a Class II device made by X6 Innovations, cleared under FDA 510(k) K231785 on 26 Jan 2024 and listed in FDA GUDID since 8 Mar 2024 (UDI-DI 03770014642295), active as of 23 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 23 Oct 2026

Documents

510(k) K231785

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03770014642295 UDI-DI Date8 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231785 Date26 Jan 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231785 decided 26 Jan 2024 Active
  • FDA GUDID UDI-DI 03770014642295 listed 8 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231785
  2. Listed FDA GUDID 03770014642295

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Perifit Pump
Generic name
Breast pump, electric
Model / reference
Perifit Pump 18mm
Primary DI / UDI-DI
03770014642295
510(k) Number
FDA product code
HGX
GMDN term
Breast pump, electric
Device class
Class II
Regulation number
884.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Breast pump, electric

Cleared under the same submission (K231785)

Similar devices

Other devices filed under FDA product code HGX (Pump, Breast, Powered).

Other devices from X6 Innovations

See all devices from X6 Innovations →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)