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Ceros RM-PF1210SF

by Rhino Medical Supply Inc

Ceros RM-PF1210SF is a Class II device made by Rhino Medical Supply Inc, cleared under FDA 510(k) K201286 on 11 Aug 2020 and listed in FDA GUDID since 18 Nov 2025 (UDI-DI 00810192690619), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K201286

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810192690619 UDI-DI Date18 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201286 Date11 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201286 decided 11 Aug 2020 Active
  • FDA GUDID UDI-DI 00810192690619 listed 18 Nov 2025 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0511-2024 FDA Class I initiated 6 Nov 2023
    • Ongoing Z-0512-2024 FDA Class I initiated 6 Nov 2023

    Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

Timeline

4 dated events

  1. Cleared FDA 510(k) K201286
  2. Recall initiated FDA recalls Z-0511-2024
  3. Recall initiated FDA recalls Z-0512-2024
  4. Listed FDA GUDID 00810192690619

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ceros
Generic name
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Model / Ref / Catalog
RM-PF1210SF
Primary DI / UDI-DI
00810192690619
510(k) Number
FDA product code
NGT
GMDN term
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 10 Milliliter

Related devices

Cleared under the same submission (K201286)

Similar devices

Other devices filed under FDA product code NGT (Saline, Vascular Access Flush).

Other devices from Rhino Medical Supply Inc

See all devices from Rhino Medical Supply Inc →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)