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The Red Cap

by Burron Medical Products, Inc.

510(k) K820454

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 NumberK820454 Date8 Mar 1982ClearedStatusActive

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  • Withdrawn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 Red Cap is a Syringe, Piston (Classification Name: 880.5860), designed as a single-use, disposable medical device for administering or withdrawing fluids. Its primary function aligns with general hospital applications, serving as a manual injection or aspiration tool in clinical settings.

Supplied as a sterile, single-use device, The Red Cap is intended for one-time use and must be discarded after use to maintain sterility. It is classified under FDA regulation 880.5860 and received FDA 510(k) clearance (K820454) in 1982 under the Traditional clearance type, with a Substantially Equivalent (SESE) determination. No additional regulatory or MRI safety information is provided in the specifications.

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Questions

AI-generated answers, 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.

  • What is The Red Cap primarily used for in clinical settings?

    The Red Cap is designed as a manual syringe for administering or withdrawing fluids, serving as a tool for injections or aspirations in general hospital applications. Its function aligns with standard syringe use in clinical environments where precise fluid control is required.

  • Is The Red Cap meant for reuse, or is it intended for single-use only?

    The Red Cap is explicitly labeled as a single-use, disposable device. It must be discarded after use to ensure sterility is maintained, as reuse could compromise its sterile integrity and safety.

  • How is The Red Cap supplied, and what does that mean for its handling?

    The Red Cap is supplied in a sterile package, meaning it is pre-sterilized and ready for immediate clinical use. This ensures safety and reduces contamination risk when preparing for administration or aspiration procedures.

  • What does the FDA clearance status of The Red Cap indicate about its regulatory path?

    The Red Cap received FDA 510(k) clearance under the Traditional clearance type in 1982 with a Substantially Equivalent (SESE) determination. This means it was deemed comparable to a legally marketed device already on the market at the time, confirming its compliance with applicable safety and performance standards.

  • Are there any special storage instructions for The Red Cap?

    While specific storage instructions aren’t detailed in the provided data, as a sterile, single-use device, The Red Cap should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity until use.