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PP-SPF1 / PP-SPF2

by Patriot Products, Inc.

510(k) K951665

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 NumberK951665 Date17 Oct 1995ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
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 PP-SPF1 / PP-SPF2 is a medical device classified under product code FPA. It is a device that has been determined to be substantially equivalent to predicate devices.

This device is manufactured by Patriot Products, Inc. and is supplied in various models as indicated by the product codes. It received FDA 510(k) clearance on October 17, 1995, with authorization number K951665. The device is intended for use in general hospital settings.

Other devices from Patriot Products, Inc.

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 PP-SPF1/SPF2 medical device used for?

    The PP-SPF1/SPF2 is a medical device intended for use in general hospital settings. It is classified under product code FPA and has been determined to be substantially equivalent to predicate devices.

  • What are the specifications and regulatory status of the PP-SPF1/SPF2?

    The PP-SPF1/SPF2 received FDA 510(k) clearance on October 17, 1995, with authorization number K951665. It is manufactured by Patriot Products, Inc. and is supplied in various models as indicated by the product codes. The device is classified under product code FPA.

  • How is the PP-SPF1/SPF2 supplied and what are its models?

    The PP-SPF1/SPF2 is supplied in various models as indicated by the product codes. The device is manufactured by Patriot Products, Inc. and is intended for use in general hospital settings. Specific model details would need to be obtained directly from the manufacturer.

  • What is the regulatory route for the PP-SPF1/SPF2 device?

    The PP-SPF1/SPF2 device received FDA 510(k) clearance on October 17, 1995, with authorization number K951665. It is classified under product code FPA and has been determined to be substantially equivalent to predicate devices.