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Monoject Pharmacy Tray

by Sherwood Medical Co.

510(k) K860688

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 NumberK860688 Date6 Aug 1987ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Monoject Pharmacy Tray is a sterile, single-use tray designed for the bulk packaging of syringes. It is classified as a Sterile Syringe Tray and supports pre-filling and batch filling procedures in hospital pharmacy settings. The trays are intended to enhance efficiency and reduce contamination risks during syringe preparation.

This device is supplied as a disposable, non-sterilised packaging solution for pre-assembled syringes, intended for use in sterile environments such as hospital pharmacies. Each tray is part of a bulk-packaged system, ensuring compliance with single-use medical device standards. The product holds FDA 510(k) clearance under reference K860688, with a product code of FMF, and was originally reviewed under the General Hospital advisory committee in 1987.

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