Skip to content

Powrsyringe Monitor

by Pinyons Medical Technology, Inc.

510(k) K072345

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072345 Date21 Sep 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Powrsyringe Monitor is a Class 2 General Hospital device with product code FMF. It is a medical device designed for monitoring syringe operations in a hospital setting.

The device was cleared through the FDA Traditional 510(k) pathway under K072345 after a 31-day review. It is manufactured by Pinyons Medical Technology, Inc. and is authorized for use in the United States.

Other devices from Pinyons Medical Technology, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Powrsyringe Monitor used for?

    The Powrsyringe Monitor is a medical device designed for monitoring syringe operations in a hospital setting, intended to track and observe syringe use during general hospital procedures to support clinical workflow and safety.

  • How is the Powrsyringe Monitor supplied and is it reusable?

    The device data does not specify supply format, sterility, or reuse characteristics; therefore, no information is available on whether it is single-use, reusable, sterile, or how it is packaged for distribution.

  • What regulatory pathway cleared the Powrsyringe Monitor?

    The Powrsyringe Monitor was cleared through the FDA Traditional 510(k) pathway under submission number K072345, following a 31-day review period, and received a substantially equivalent (SESE) decision on September 21, 2007.