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DeRoyal 83-000107

by Deroyal Industries, Inc.

DeRoyal 83-000107 is an anaesthesia breathing circuit (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by Deroyal Industries, Inc., cleared under FDA 510(k) K946044 on 27 Dec 1994 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00749756138383), active as of 23 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 23 Oct 2026

Documents

510(k) K946044

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00749756138383 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK946044 Date27 Dec 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K946044 decided 27 Dec 1994 Active
  • FDA GUDID UDI-DI 00749756138383 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K946044
  2. Listed FDA GUDID 00749756138383

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DeRoyal
Generic name
Anaesthesia breathing circuit, single-use
Model / reference
83-000107
Primary DI / UDI-DI
00749756138383
510(k) Number
FDA product code
CCK
GMDN term
Anaesthesia breathing circuit, single-use
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Anaesthesia breathing circuit, single-use

Cleared under the same submission (K946044)

and 8 more cleared under K946044

Similar devices in this category

Other devices filed under Anaesthesia breathing circuit, single-use.

Other devices from Deroyal Industries, Inc.

See all devices from Deroyal Industries, Inc. →

Properties

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