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Patient Safe Luer Cap

by Retractable Technologies, Inc.

510(k) K101708

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101708 Date24 Feb 2011ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 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 Patient Safe Luer Cap is a Luer Lock Cap designed to reduce touch contamination and prevent medication leakage during use. It is intended for attachment to luer-tip syringes and other compatible devices to enhance aseptic technique and improve safety in clinical settings. Constructed to maintain sterility and minimize exposure risks, it aligns with standards for syringe accessories in healthcare environments.

This device is supplied as a single-use item and is intended for use in general hospital settings. It is not classified as MRI-safe or reusable, and no specific sterility assurance beyond standard manufacturing controls is stated. The cap is available in a single reference code, M-826, and must be stored according to manufacturer guidelines to preserve its integrity. Its regulatory status includes FDA 510(k) clearance (K101708) under the Traditional 510(k) Review pathway, with no third-party involvement.

From the manufacturer

Retractable Technologies delivers automated retractable syringe & needle safety solutions that reduce needlestick injuries, reduce waste, & protect healthcare workers.

Source: retractable.com

Devices cleared under K101708

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K101708
UDI-DISize and differences
Patient Safe® 51021
Retractable Technologies, Inc.
51021 / 5102100613703510204 —On the market

Similar devices

Other devices filed under FDA product code FMF (Syringe, Piston).

Other devices from Retractable Technologies, Inc.

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