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Nc-2025-8F

by Southmedic Incorporated

Nc-2025-8F is a Class II device made by Southmedic Incorporated, cleared under FDA 510(k) K131410 on 13 Jan 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 10620974001376), 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) K131410

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 Number10620974001376 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131410 Date13 Jan 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131410 decided 13 Jan 2014 Active
  • FDA GUDID UDI-DI 10620974001376 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131410
  2. Listed FDA GUDID 10620974001376

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Nasal oxygen cannula, carbon-dioxide-sampling
Model / Ref / Catalog
NC-2025-8F
Primary DI / UDI-DI
10620974001376
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

Related devices

Category: Nasal oxygen cannula, carbon-dioxide-sampling

Cleared under the same submission (K131410)

and 2 more cleared under K131410

Other devices from Southmedic Incorporated

See all devices from Southmedic Incorporated →

Properties

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