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Rumble Tuff 200DP

by A Cute Baby, Inc.

Rumble Tuff 200DP is a Class II device made by A Cute Baby, Inc., cleared under FDA 510(k) K113315 on 20 Nov 2012 and listed in FDA GUDID since 3 Dec 2025 (UDI-DI 00879388001097), 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) K113315

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 Number00879388001097 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113315 Date20 Nov 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113315 decided 20 Nov 2012 Active
  • FDA GUDID UDI-DI 00879388001097 listed 3 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113315
  2. Listed FDA GUDID 00879388001097

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rumble Tuff
Generic name
Breast pump, electric
Model / reference
200DP
Primary DI / UDI-DI
00879388001097
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

Cleared under the same submission (K113315)

Similar devices

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

Other devices from A Cute Baby, Inc.

See all devices from A Cute Baby, Inc. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)