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SmartBlock Pain Pump

by Medical Flow Systems, Ltd.

510(k) K072053

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK072053 Date6 Nov 2007ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1981-2011 FDA Unclassified (pre-2012) initiated 17 Mar 2010

    Elastomeric tube in product's compression unit has the potential to burst following filling.

    • Terminated Z-1022-2010 FDA Unclassified (pre-2012) initiated 8 Jan 2009

    Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.

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  • Withdrawn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
MEB
Device Class
Class II
Regulation
21 CFR Part 880.5725
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 SmartBlock Pain Pump is an elastomeric infusion pump designed for continuous or intermittent delivery of medication to surgical wound sites or near nerves. It is classified as a Class II medical device and serves as a tool for preoperative, perioperative, and postoperative regional anesthesia and pain management.

This device is supplied as a single-use, non-sterile elastomeric pump and is regulated under FDA 510(k) clearance (K072053). It is intended for use in general hospital settings and adheres to regulatory standards outlined in 21 CFR 880.5725. No MRI safety information or reusable specifications are provided in the available data.

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