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15 mm Adaptor 311004

by Boston Medical Products, Inc.

15 mm Adaptor 311004 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 20 Sep 2015 (UDI-DI EBES3110040), 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 NumberEBES3110040 UDI-DI Date20 Sep 2015ListedStatusListed 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 EBES3110040 listed 20 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K802916
  2. Listed FDA GUDID EBES3110040

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
15 mm Adaptor
Generic name
Straight/elbow breathing circuit connector, single-use
Model / Ref / Catalog
311004
Primary DI / UDI-DI
EBES3110040
510(k) Number
FDA product code
BTO
GMDN term
Straight/elbow breathing circuit connector, single-use
Device class
Class II
Regulation number
868.5800
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices in this category

Other devices filed under Straight/elbow breathing circuit connector, single-use.

Other devices from Boston Medical Products, Inc.

See all devices from Boston Medical Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)