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McKinley SP Disposable Infusion Pump

by Mckinley, Inc.

510(k) K990461

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 NumberK990461 Date30 Jun 1999ClearedStatusActive

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  • Withdrawn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
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 McKinley SP Disposable Infusion Pump is an elastomeric infusion device designed for continuous, controlled delivery of fluids or medications. It falls under the classification of Pump, Infusion, Elastomeric (product code MEB) and is intended for single-use applications in clinical settings.

This device is supplied as a disposable, intended for use in general hospital environments. It is regulated under FDA 510(k) clearance (K990461) and classified as a Class II medical device. The pump is engineered for intravenous, intra-arterial, enteral, subcutaneous, and epidural administration, as well as postoperative pain management via local anesthetic infusion.

Other devices from Mckinley, Inc.

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 types of fluid or medication administration routes can the McKinley SP Disposable Infusion Pump be used for?

    The McKinley SP Disposable Infusion Pump is designed for multiple administration routes, including intravenous, intra-arterial, enteral, subcutaneous, and epidural delivery. It is also suitable for postoperative pain management via local anesthetic infusion, making it versatile for various clinical scenarios.

  • Is the McKinley SP Disposable Infusion Pump intended for single-use or reusable applications?

    The McKinley SP Disposable Infusion Pump is explicitly designed for single-use applications only, ensuring patient safety and compliance with clinical hygiene standards in hospital settings.

  • How is the McKinley SP Disposable Infusion Pump supplied, and what clinical environments is it intended for?

    The pump is supplied as a disposable device and is intended for use in general hospital environments. It is engineered to provide controlled, continuous fluid or medication delivery in settings where sterile, single-use infusion systems are required.

  • What regulatory pathway was followed for FDA clearance of the McKinley SP Disposable Infusion Pump?

    The McKinley SP Disposable Infusion Pump received FDA 510(k) clearance (K990461) under the Traditional Review pathway, classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and reviewed by the General Hospital (HO) Advisory Committee.