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Inca 44-2001

by CooperSurgical, Inc.

Inca 44-2001 is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K911780 on 24 Jun 1991 and listed in FDA GUDID since 8 Jul 2016 (UDI-DI 60888937009530), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K911780

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 Number60888937009530 UDI-DI Date8 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK911780 Date24 Jun 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K911780 decided 24 Jun 1991 Active
  • FDA GUDID UDI-DI 60888937009530 listed 8 Jul 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3140-2026 FDA Class I initiated 11 Aug 2026
    • Ongoing Z-3139-2026 FDA Class I initiated 11 Aug 2026

    Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

Timeline

4 dated events

  1. Cleared FDA 510(k) K911780
  2. Listed FDA GUDID 60888937009530
  3. Recall initiated FDA recalls Z-3140-2026
  4. Recall initiated FDA recalls Z-3139-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Inca
Generic name
Nasal oxygen cannula, CPAP
Model / reference
44-2001
Primary DI / UDI-DI
60888937009530
510(k) Number
FDA product code
BZD
GMDN term
Nasal oxygen cannula, CPAP
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal oxygen cannula, CPAP

Cleared under the same submission (K911780)

and 8 more cleared under K911780

Similar devices in this category

Other devices filed under Nasal oxygen cannula, CPAP.

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Single use
  • Prescription use
Other properties (13, all answered No)