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Antispil 9010-H

by Southmedic Incorporated

Part of a family of 7 devices: see the family page

Ref 9010-HModel 8907-S

Antispil 9010-H is a device classified as Class I in the EU and Class II in the US made by Southmedic Incorporated, registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI 6209740064131918B4), cleared under FDA 510(k) K945993 on 22 Feb 1995 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 10620974002014), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None, self-declared

Class I: no certifier involved

510(k) K945993

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6209740064131918B4 Basic UDI-DI 10620974002014UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10620974002014 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK945993 Date22 Feb 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6209740064131918B4 registered 6 Aug 2026 Active
  • FDA 510(k) K945993 decided 22 Feb 1995 Active
  • FDA GUDID UDI-DI 10620974002014 listed 1 Sep 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1190-06 FDA Unclassified (pre-2012) initiated 21 Apr 2006
    • Terminated Z-1189-06 FDA Unclassified (pre-2012) initiated 21 Apr 2006

    Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.

Timeline

5 dated events

  1. Cleared FDA 510(k) K945993
  2. Recall initiated FDA recalls Z-1190-06
  3. Recall initiated FDA recalls Z-1189-06
  4. Listed FDA GUDID 10620974002014
  5. Registered EUDAMED 6209740064131918B4

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
Anti-Spil EUDAMED
Antispil GUDID
Generic name
Halothane anaesthesia vaporizer
Device name
VapoFil Keyed Anesthetic Agent Adapter
Model / Ref / Catalog
9010-H, 8907-S
Primary DI / UDI-DI
10620974002014
Basic UDI-DI
6209740064131918B4
510(k) Number
FDA product code
CAD
EMDN code
R9099 Respiratory and anaesthesia devices - other
GMDN term
Halothane anaesthesia vaporizer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
868.5880
EU registration type
Standard device
EU market of registration
Netherlands
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: Halothane anaesthesia vaporizer

Cleared under the same submission (K945993)

Similar devices in this category

Other devices filed under RESPIRATORY AND ANAESTHESIA DEVICES - OTHER.

Other devices from Southmedic Incorporated

See all devices from Southmedic Incorporated →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)