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SmartInfuser PainPump, Model P49220 W/Catheter Set; P49224N W/O Catheter Set

by Precise Medical Products, Ltd.

510(k) K061409

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 · Special NumberK061409 Date16 Jun 2006ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1982-2011 FDA Unclassified (pre-2012) initiated 17 Mar 2010

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

    • Terminated Z-1021-2010 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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 SmartInfuser PainPump is an elastomeric infusion pump designed for the continuous delivery of local anesthetic. It is substantially equivalent to a legally marketed device and classified as a Class II medical device under FDA regulation 880.5725.

The device is supplied with or without a catheter set, as indicated by model numbers P49220 (with catheter set) and P49224N (without catheter set). It is intended for use in a general hospital setting for postoperative pain management, as stated in the indications for use from the premarket notification.

Other devices from Precise Medical Products, Ltd.

Questions

AI-generated answers, 26 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 SmartInfuser PainPump used for?

    The SmartInfuser PainPump is designed for the continuous delivery of local anesthetic in postoperative pain management. It is intended for use in a general hospital setting, as stated in its indications for use from the premarket notification.

  • How is the SmartInfuser PainPump supplied and what models are available?

    The device is supplied with or without a catheter set. Model P49220 includes the catheter set, while model P49224N is provided without it. These model numbers distinguish the two configurations as indicated in the device data.

  • Is the SmartInfuser PainPump a single-use or reusable device?

    As an elastomeric infusion pump designed for continuous delivery of local anesthetic, the SmartInfuser PainPump is intended for single-use. Elastomeric pumps of this type are typically discarded after the infusion is complete, consistent with their design for safe, controlled drug delivery in postoperative care.