K SERIES CPAP SYSTEMS— 510(k) K123897

Name: FDA 510(k) clearance K123897
Creator: U.S. Food and Drug Administration
Published: 2013-03-13

Substantially Equivalent

Curative Medical, Inc.

FDA 510(k) clearance K123897 for K SERIES CPAP SYSTEMS, Substantially Equivalent on 2013-03-13. Applicant: Curative Medical, Inc.. Device class: 2.

Clearance details

Applicant: Curative Medical, Inc.
Product code: Code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2012-12-18
Decision date: 2013-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Fulshear, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZD

view all

K253044 — RXiBreeze PAP System (RXiBreeze 20C)2026-07-23
K253553 — Orion2026-06-04
K254104 — ResScan Essentials2026-05-27
K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask2026-05-21
K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)2026-04-29

More clearances from Curative Medical, Inc.

view all

K141354 — NAVAJO PTA BALLOON DILATATION CATHETER2015-01-30
K130828 — K SERIES CPAP SYSTEMS2014-01-13
K131702 — K SERIES CPAP SYSTEMS2013-12-06
K130663 — BESTFIT2 NASAL MASK2013-09-27
K120285 — K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER2012-07-02

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.