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Pentair 100061000

by Pentair Filtration Solutions

Pentair 100061000 (DFC0676M03N) is a Class II device made by Pentair Filtration Solutions, cleared under FDA 510(k) K061426 on 5 Jun 2006 and listed in FDA GUDID since 31 Dec 2017 (UDI-DI B4621000610003), 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) K061426

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 NumberB4621000610003 UDI-DI Date31 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061426 Date5 Jun 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061426 decided 5 Jun 2006 Active
  • FDA GUDID UDI-DI B4621000610003 listed 31 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061426
  2. Listed FDA GUDID B4621000610003

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pentair
Generic name
Non-respiratory device ambient air filter
Model / Ref / Catalog
100061000, DFC0676M03N
Primary DI / UDI-DI
B4621000610003
510(k) Number
FDA product code
CAH
GMDN term
Non-respiratory device ambient air filter
Device class
Class II
Regulation number
868.5260
GUDID distribution status
In Commercial Distribution

Related devices

Category: Non-respiratory device ambient air filter

Cleared under the same submission (K061426)

and 8 more cleared under K061426

Similar devices

Other devices filed under FDA product code CAH (Filter, Bacterial, Breathing-Circuit).

Other devices from Pentair Filtration Solutions

See all devices from Pentair Filtration Solutions →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)