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Blade Safe

by Instranetics, Inc.

510(k) K810208

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 NumberK810208 Date12 Feb 1981ClearedStatusActive

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  • Withdrawn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
MMK
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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 Blade Safe is a container designed for sharps, classified under FDA product code MMK. It is intended to safely hold and transport used surgical blades and other sharp instruments, reducing the risk of needlestick injuries and ensuring proper disposal.

This device is supplied as a reusable container and is intended for use in general hospital settings. It has received FDA 510(k) clearance under the Traditional pathway, with a decision date of February 12, 1981. The device is not specified as single-use or sterile, and no MRI safety information is provided. It is regulated under regulation number 880.5570 and falls under device class II.

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Questions

AI-generated answers, 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.

  • What is the Blade Safe designed for?

    The Blade Safe is a reusable container specifically designed to safely hold and transport used surgical blades and other sharp instruments. Its purpose is to minimize the risk of needlestick injuries during disposal, ensuring sharps are contained securely in general hospital environments.

  • Is the Blade Safe intended for single-use or reuse?

    The Blade Safe is supplied as a reusable container. Unlike single-use devices, it is engineered for repeated use in clinical settings, reducing waste and operational costs over time.

  • What type of sterility or cleaning requirements apply to the Blade Safe?

    The Blade Safe is not specified as sterile, meaning it is not pre-sterilized for immediate clinical use. However, as a reusable device, it must be cleaned and disinfected between uses to maintain safety and hygiene standards.

  • Does the Blade Safe have any specific regulatory approvals?

    The Blade Safe has received FDA 510(k) clearance under the Traditional pathway, with a decision date of February 12, 1981. This approval confirms its compliance with U.S. regulatory standards for sharps containers in general hospital settings.

  • How is the Blade Safe classified under FDA regulations?

    The Blade Safe falls under FDA product code MMK and is classified as a Class II device, regulated under regulation number 880.5570. This classification indicates moderate risk, requiring pre-market notification (510(k)) to demonstrate substantial equivalence to a predicate device.