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Strato PCA Infuser

by Strato Medical Corp.

510(k) K864808

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 NumberK864808 Date21 Jan 1987ClearedStatusActive

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  • Withdrawn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)

Full name
Strato(R) Pca Infuser
510(k) Number
FDA Product Code
FRN
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 device is an infusion pump, specifically a patient-controlled analgesia (PCA) infuser, as indicated by its device name and classification. It is a Class II medical device cleared under the FDA 510(k) process with product code FRN and regulation number 880.5725.

It was manufactured by Strato Medical Corp. and received FDA 510(k) clearance (K864808) on January 21, 1987, following a traditional review process. The device is intended for general hospital use and is identified by its model name and associated registration and FEI numbers.

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