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NeedleSmart Professional (NS Pro)

by Needlesmart Limited

510(k) K202073

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202073 Date25 Mar 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MTV
Device Class
Class II
Regulation
21 CFR Part 880.6210
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 NeedleSmart Professional (NS Pro) is a Sharps Needle Destruction Device (Product Code: MTV), classified as a Class II medical device under FDA regulation 880.6210. It is designed to safely process and neutralise hypodermic needles by rendering them non-sharp, thereby mitigating the risk of accidental needle-stick injuries in clinical settings.

This device is intended for use by healthcare professionals in general hospital environments. It operates as a single-use, non-sterile system, supplied ready for immediate use without additional preparation. The device is authorised under FDA 510(k) clearance (K202073) and is intended for use in compliance with local sharps disposal regulations.

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 NeedleSmart Professional (NS Pro) designed to do in a clinical setting?

    The NeedleSmart Professional (NS Pro) is specifically designed to safely process and neutralize hypodermic needles by rendering them non-sharp. This reduces the risk of accidental needle-stick injuries, which is particularly important in general hospital environments where sharps disposal must be handled carefully.

  • Is the NeedleSmart Professional (NS Pro) reusable or single-use, and does it require any preparation before use?

    The NeedleSmart Professional (NS Pro) is a single-use device and is supplied ready for immediate use without any additional preparation. This ensures convenience and reduces the risk of cross-contamination or improper handling before use.

  • How is the NeedleSmart Professional (NS Pro) classified, and what type of regulatory clearance does it hold?

    The NeedleSmart Professional (NS Pro) is classified as a Class II medical device under FDA regulation 880.6210 and is authorized through FDA 510(k) clearance (K202073). It is intended for use in compliance with local sharps disposal regulations, ensuring it meets established safety and performance standards.

  • Is the NeedleSmart Professional (NS Pro) sterile, and what type of environment is it intended for?

    The NeedleSmart Professional (NS Pro) is a non-sterile device, which is typical for sharps disposal systems that do not come into direct contact with sterile fields. It is intended for use by healthcare professionals in general hospital environments, where its primary purpose is to safely neutralize needles post-use.