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Phantom 2550-2

by Innovative Med, Inc.

Phantom 2550-2 (IM-K2550-2) is a Class II device made by Innovative Med, Inc., cleared under FDA 510(k) K895761 on 18 Oct 1989 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00851314007007), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K895761

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851314007007 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK895761 Date18 Oct 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K895761 decided 18 Oct 1989 Active
  • FDA GUDID UDI-DI 00851314007007 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K895761
  2. Listed FDA GUDID 00851314007007

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Phantom
Generic name
General-purpose surgical suction system, vacuum
Model / Ref / Catalog
2550-2, IM-K2550-2
Description
Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 in. hg. @ sea level, 230 VAC
Primary DI / UDI-DI
00851314007007
510(k) Number
FDA product code
JCX
GMDN term
General-purpose surgical suction system, vacuum
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose surgical suction system, vacuum

Cleared under the same submission (K895761)

Similar devices

Other devices filed under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered).

Other devices from Innovative Med, Inc.

See all devices from Innovative Med, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)