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KV-6 Suction Pump 200.5625

by Medela LLC 4 variants

KV-6 Suction Pump 200.5625 (K10026146) is a Class II device made by Medela LLC, cleared under FDA 510(k) K150134 on 21 Apr 2015 and listed in FDA GUDID since 3 Oct 2016 (UDI-DI 07612367044967), 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) K150134

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 Number07612367044967 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150134 Date21 Apr 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150134 decided 21 Apr 2015 Active
  • FDA GUDID UDI-DI 07612367044967 listed 3 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150134
  2. Listed FDA GUDID 07612367044967

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
KV-6 Suction Pump
Generic name
Surgical suction pump
Model / Ref / Catalog
200.5625, K10026146
Primary DI / UDI-DI
07612367044967
510(k) Number
FDA product code
BTA
GMDN term
Surgical suction pump
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Surgical suction pump

Cleared under the same submission (K150134)

and 8 more cleared under K150134

Other devices from Medela LLC

See all devices from Medela LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)