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Haemonetics LRF10S

by Haemonetics Corporation

Haemonetics LRF10S is a Class II device made by Haemonetics Corporation, listed under FDA premarket submission BK910019 and listed in FDA GUDID since 18 Jan 2017 (UDI-DI 10887691000437), 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) BK910019

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 Number10887691000437 UDI-DI Date18 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberBK910019 Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA premarket submission BK910019 Active
  • FDA GUDID UDI-DI 10887691000437 listed 18 Jan 2017 Listed

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Haemonetics
Generic name
Blood transfusion filter
Model / reference
LRF10S
Primary DI / UDI-DI
10887691000437
FDA product code
CAK
GMDN term
Blood transfusion filter
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood transfusion filter

Cleared under the same submission (BK910019)

and 2 more cleared under BK910019

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)