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Curaplex 5107F-SE-E

by Bound Tree Medical, LLC

Curaplex 5107F-SE-E (301-5107F-SE-E) is a Class II device made by Bound Tree Medical, LLC, cleared under FDA 510(k) K063813 on 26 Mar 2008 and listed in FDA GUDID since 30 Sep 2021 (UDI-DI 00810071631801), active as of 22 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 22 Oct 2026

Documents

510(k) K063813

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810071631801 UDI-DI Date30 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063813 Date26 Mar 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063813 decided 26 Mar 2008 Active
  • FDA GUDID UDI-DI 00810071631801 listed 30 Sep 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063813
  2. Listed FDA GUDID 00810071631801

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Curaplex
Generic name
Nasal oxygen cannula, carbon-dioxide-sampling
Model / Ref / Catalog
5107F-SE-E, 301-5107F-SE-E
Primary DI / UDI-DI
00810071631801
510(k) Number
FDA product code
CCK
GMDN term
Nasal oxygen cannula, carbon-dioxide-sampling
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution
Size
Length — 7 Feet

Related devices

Category: Nasal oxygen cannula, carbon-dioxide-sampling

Cleared under the same submission (K063813)

and 8 more cleared under K063813

Similar devices

Other devices filed under FDA product code CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE).

Other devices from Bound Tree Medical, LLC

See all devices from Bound Tree Medical, LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)