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Terfusion Final Filter Set

by Terumo Medical Corp.

510(k) K810113

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 NumberK810113 Date27 Mar 1981ClearedStatusActive

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  • Withdrawn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
FPB
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 Terfusion Final Filter Set is a filter for infusion lines, classified as a Class II medical device under FDA regulation 880.5440 with product code FPB. It is substantially equivalent to a legally marketed predicate device as determined by FDA 510(k) clearance K810113.

The device is manufactured by Terumo Medical Corp. and was cleared via the traditional 510(k) pathway on March 27, 1981, following receipt on January 6, 1981. It is intended for use in general hospital settings and is supplied as a finished device under the authorization of FDA 510(k) clearance.

From the manufacturer

Terumo Medical Corporation provides a comprehensive list of its products and affiliated divisions.

Source: terumomedical.com

Terumo is one of the world's leading manufacturers of medical devices and supplies. We perform our own research and development, manufacturing, marketing, distribution and sales of medical devices.

Source: terumomedical.com

Other devices from Terumo Medical Corporation

See all devices from Terumo Medical Corporation →

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 Terfusion Final Filter Set used for?

    The Terfusion Final Filter Set is a filter designed for infusion lines, intended for use in general hospital settings to remove particulates from intravenous fluids during administration.

  • How is the Terfusion Final Filter Set supplied and is it sterile?

    The device is supplied as a finished device under FDA 510(k) clearance, meaning it is provided sterile and ready for immediate clinical use without further processing by the end user.

  • Is the Terfusion Final Filter Set reusable or single-use?

    As a finished infusion line filter supplied sterile and cleared via 510(k), the Terfusion Final Filter Set is intended for single-use only to maintain sterility and prevent cross-contamination between patients.

  • What regulatory pathway was used for the Terfusion Final Filter Set?

    The device was cleared through the traditional FDA 510(k) pathway under clearance number K810113, demonstrating substantial equivalence to a legally marketed predicate device.

  • What class is the Terfusion Final Filter Set and what regulation applies?

    The Terfusion Final Filter Set is classified as a Class II medical device under FDA regulation 880.5440, with product code FPB, indicating its classification as an infusion line filter.