510(k) Report

FDA applicant

Remington Medical, Inc.

Alpharetta, GA19 decisions1993–202514 recalls

FDA records 19 decisions for Remington Medical, Inc. (Alpharetta, GA) from 1993 to 2025: 19 510(k) clearances. Most are in product codes DPW (Flowmeter, Blood, Cardiovascular) and KNW (Instrument, Biopsy). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 3 of them its own earlier devices. 14 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Remington Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2013: 12015: 12019: 12021: 12022: 12024: 12025: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2007: 22010: 12011: 52012: 12014: 12022: 12023: 1
2007high 5 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Remington Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Remington Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DPWFlowmeter, Blood, Cardiovascular4decisions
  • KNWInstrument, Biopsy4decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)2decisions
  • LHISet, I.V. Fluid Transfer1decision
  • IZHSystem, X-Ray, Mammographic1decision
  • EXFBag, Bile Collecting1decision

Also: DTE (1), BSP (1), DTA (1), KHR (1), DYB (1), KKX (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 153 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerRemington Medical, Inc. · 20212cite it
  • K971968Safe Connect Surgical Cable (S-101-97/S-201-97/FL-601-97)Remington Medical, Inc. · 19972cite it
  • K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc. · 20221cites it
  • K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01…Remington Medical, Inc. · 20241cites it

What has FDA decided for it lately?

  • K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02…Remington Medical, Inc. · 2025
  • K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01…Remington Medical, Inc. · 2024
  • K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc. · 2022
  • K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerRemington Medical, Inc. · 2021
  • K191315Remington Medical, Inc. Automatic Cutting Needle (NAC)Remington Medical, Inc. · 20191 recall
  • K150266Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc. · 2015
  • K130282Remington Medical Centrefire 22 Biopsy InstrumentRemington Medical, Inc. · 2013
  • K050884Adapter CableRemington Medical, Inc. · 20051 recall

All 19 as Remington Medical, Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K990428Remington MEDICAL Drainage Bag, REF 600-D;Nov 3, 2023Class II
  • K191315Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)Dec 2, 2022Class II
  • K971968FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical…Mar 5, 2014Class II
  • K982401Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington…Aug 29, 2012Class II
  • K040266Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825M, 18ga (1.3mm) x 25cm…Feb 7, 2011
  • K040266Automatic Cutting Needle, Soft Tissue Biopsy Needle, NAC-1825MLL, 18ga (1.3mm) x 25cm…Feb 7, 2011

Other applicant names beginning “Remington”

FDA records each applicant name separately; these may or may not be the same firm.

Remington Products Company, LLC 3