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Fusion

by Burke, Inc.

510(k) K061912

Fusion is a medical device (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Burke, Inc., cleared under FDA 510(k) K061912 on 1 Aug 2006, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061912 Date1 Aug 2006ClearedStatusActive

Official records

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  • Withdrawn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
INI
Device class
Class II
Regulation
21 CFR Part 890.3800
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Devices cleared under K061912

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K061912
UDI-DISize and differences
Pacesave Fusion 500
Burke, Inc.
15090 / Fusion 500B314150901 —On the market
PaceSaver Fusion 250
Burke, Inc.
17478 / Fusion 250B314174781 —On the market
Pacesaver Fusion 350
Burke, Inc.
17477 / Fusion 350B314174771 —On the market
Pacesaver Fusion 450
Burke, Inc.
15085 / Fusion 450B314150851 —On the market

Similar devices

Other devices filed under FDA product code INI (Vehicle, Motorized 3-Wheeled).

Other devices from Burke, Inc.

See all devices from Burke, Inc. →