Skip to content

Sof Set, Models 111 and 112

by Pacesetter Systems 510(k)

Active United States

510(k) K861436

Overview

This device is a pump infusion system, as defined in the device name and classification data. It is a substantially equivalent device cleared under FDA 510(k) K861436 for general hospital use.

It is supplied as a medical device with product code FRN, classified as FDA class 2, and regulated under regulation number 880.5725. The device was received for review on April 17, 1986, and cleared on June 9, 1986, by Pacesetter Systems.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK861436 Date9 Jun 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Other devices from Pacesetter Systems

See all devices from Pacesetter Systems →

Questions

  • What is the SOF SET Models 111 and 112 used for?

    The SOF SET Models 111 and 112 is a pump infusion system intended for general hospital use, as defined in its device name and classification data, and cleared as substantially equivalent under FDA 510(k) K861436.

  • How is the SOF SET Models 111 and 112 supplied and what is its product code?

    The device is supplied as a medical device with product code FRN, classified as FDA class 2, and regulated under regulation number 880.5725 for general hospital infusion applications.

  • What regulatory clearance does the SOF SET Models 111 and 112 have?

    The SOF SET Models 111 and 112 was cleared under FDA 510(k) K861436 on June 9, 1986, after being received for review on April 17, 1986, as a substantially equivalent device for general hospital use.