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Megadyne 2550J

by Megadyne Medical Products, Inc.

Ref 2550J

Megadyne 2550J is a device classified as Class I in the EU and Class II in the US made by Megadyne Medical Products, Inc., registered in EUDAMED on 24 Oct 2025 (Basic UDI-DI 0614559a00013BQ), cleared under FDA 510(k) K200250 on 26 Jun 2020 and listed in FDA GUDID since 3 Aug 2020 (UDI-DI 10614559104552), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200250

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0614559a00013BQ Basic UDI-DI 10614559104552UDI-DIDate24 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10614559104552 UDI-DI Date3 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200250 Date26 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0614559a00013BQ registered 24 Oct 2025 Active
  • FDA 510(k) K200250 decided 26 Jun 2020 Active
  • FDA GUDID UDI-DI 10614559104552 listed 3 Aug 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200250
  2. Listed FDA GUDID 10614559104552
  3. Registered EUDAMED 0614559a00013BQ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Megadyne
Generic name
Surgical plume evacuation system filter
Device name
MEGADYNE Filter
Model / Ref / Catalog
2550J
Primary DI / UDI-DI
10614559104552
Basic UDI-DI
0614559a00013BQ
Direct marketing DI
10614559104552
510(k) Number
FDA product code
FYD
EMDN code
K02010107 Smoke evacuation systems
GMDN term
Surgical plume evacuation system filter
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.5070
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Surgical plume evacuation system filter

Cleared under the same submission (K200250)

Similar devices in this category

Other devices filed under SMOKE EVACUATION SYSTEMS.

Other devices from Megadyne Medical Products, Inc.

See all devices from Megadyne Medical Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)