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Acci-Guard Multi-Sample Blood Collection Needle

by Medical Safety Products, Inc.

510(k) K881654

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 NumberK881654 Date8 Jul 1988ClearedStatusActive

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  • Withdrawn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
FMI
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 Acci-Guard Multi-Sample Blood Collection Needle is a device used for blood collection procedures. It is designed to allow for multiple blood samples to be collected using a single needle insertion.

This device is supplied as a single-use item and is not for reuse. It is not MRI compatible. The device has received FDA 510(k) clearance with product code FMI and is manufactured by Medical Safety Products, Inc.

Other devices from Medical Safety Products, Inc.

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 Acci-Guard Multi-Sample Blood Collection Needle used for?

    The Acci-Guard Multi-Sample Blood Collection Needle is designed for blood collection procedures, enabling healthcare professionals to collect multiple blood samples using a single needle insertion, which improves efficiency during blood draws.

  • Is the Acci-Guard Blood Collection Needle reusable or single-use?

    The Acci-Guard Multi-Sample Blood Collection Needle is supplied as a single-use item and is not intended for reuse. This design helps prevent cross-contamination between patients and ensures safety during blood collection procedures.

  • What regulatory approvals does the Acci-Guard Blood Collection Needle have?

    The device has received FDA 510(k) clearance with product code FMI. This clearance indicates that the device is substantially equivalent to other legally marketed devices in the United States for its intended use.

  • Is the Acci-Guard Blood Collection Needle MRI compatible?

    No, the Acci-Guard Multi-Sample Blood Collection Needle is not MRI compatible. Healthcare providers should ensure alternative methods are used when blood collection is required for patients undergoing MRI procedures.