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HIgH-Flo™ Needle Set RMS12412

by Repro Med Systems, Inc.

Ref RMS12412Model High-Flo Subcutaneous Safety Needle Sets

HIgH-Flo™ Needle Set RMS12412 is a device classified as Class IIa in the EU and Class II in the US made by Repro Med Systems, Inc., registered in EUDAMED on 1 Jul 2026 (Basic UDI-DI B-00659443000551), cleared under FDA 510(k) K252015 on 28 Jan 2026 (4 earlier submissions) and listed in FDA GUDID since 19 Aug 2016 (UDI-DI 00659443000551), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252015

+4 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00659443000551 Basic UDI-DI 00659443000551UDI-DIDate1 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK252015 Date28 Jan 2026DecidedStatusActive
United StatesGUDID listing GUDID Number00659443000551 UDI-DI Date19 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00659443000551 registered 1 Jul 2026 Active
  • FDA 510(k) K252015 decided 28 Jan 2026 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00659443000551 listed 19 Aug 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0051-2020 FDA Class II initiated 20 Aug 2019

    Mislabeled needle lengths

    • Terminated Z-0318-2018 FDA Class II initiated 10 Mar 2016

    On 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part number #317036 5 X 6.5 ST Bag Combo. the firm decided to recall Precision Flow Rate Tubing and RMS HIgH-Flo Subcutaneous Safety Needles Sets due to the sterile barrier packaging being found to have gaps during post-sterilization inspection of one lot of flow tubing, in which 701 out of 3,195 units were rejected for not passing inspection. The firm determined that the issue was large than just the one lot and recalled the product via March 10, 2016 Voluntary Medical Device Corrections and Removal Notification to customers. The recall was conducted without FDA notification.

Timeline

9 dated events

  1. Cleared FDA 510(k) K122404
  2. Recall initiated FDA recalls Z-0318-2018
  3. Listed FDA GUDID 00659443000551
  4. Recall initiated FDA recalls Z-0051-2020
  5. Cleared FDA 510(k) K211206
  6. Cleared FDA 510(k) K200176
  7. Cleared FDA 510(k) K214045
  8. Cleared FDA 510(k) K252015
  9. Registered EUDAMED B-00659443000551

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
High-Flo Subcutaneous Safety Needle Sets EUDAMED
HIgH-Flo™ Needle Set GUDID
Generic name
Subcutaneous infusion/injection port needle
Model / Ref / Catalog
RMS12412, High-Flo Subcutaneous Safety Needle Sets
Primary DI / UDI-DI
00659443000551
Basic UDI-DI
B-00659443000551
510(k) Number
FDA product code
FPA
EMDN code
A010199 Needles for infusion and collection - other
GMDN term
Subcutaneous infusion/injection port needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.5440
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
MRI safety
MR Unsafe
Size
Needle Gauge — 24 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00659443000551: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Subcutaneous infusion/injection port needle

Cleared under the same submission (K122404)

and 8 more cleared under K122404

Cleared under the same submission (K200176)

and 8 more cleared under K200176

Similar devices in this category

Other devices filed under NEEDLES FOR INFUSION AND COLLECTION - OTHER.

Other devices from Repro Med Systems, Inc.

See all devices from Repro Med Systems, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)