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Cannula Faceplate 310403

by Boston Medical Products, Inc. 2 variants

Cannula Faceplate 310403 is a Class II device made by Boston Medical Products, Inc., cleared under FDA 510(k) K802916 on 19 Dec 1980 and listed in FDA GUDID since 29 Sep 2022 (UDI-DI 14063107100021), 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) K802916

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 Number14063107100021 UDI-DI Date29 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK802916 Date19 Dec 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K802916 decided 19 Dec 1980 Active
  • FDA GUDID UDI-DI 14063107100021 listed 29 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K802916
  2. Listed FDA GUDID 14063107100021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cannula Faceplate
Generic name
Tracheostomy tube dressing
Model / Ref / Catalog
310403
Primary DI / UDI-DI
14063107100021
510(k) Number
FDA product code
BTO
GMDN term
Tracheostomy tube dressing
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Tracheostomy tube dressing

Cleared under the same submission (K802916)

and 8 more cleared under K802916

Similar devices

Other devices filed under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)).

Other devices from Boston Medical Products, Inc.

See all devices from Boston Medical Products, Inc. →

Properties

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