510(k) · Cleared

Recalled · Class I · 2018

Cpap/Vpap Masks, Models 1225, 1205 and 1235

K063268510(k) TraditionalCleared Feb 23, 2007116-day reviewClass II21 CFR 868.5905Recalls 1 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hsiner Co., Ltd. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Feb 23, 2007 as substantially equivalent to K002465 (Respironics, Inc., 2000) and 3 other predicates after a 116-day review. Its family tree reaches back 3 generations to 1983. 1 of the 13 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Feb 23, 2007
Review: 116 days
Class: Class II
Product code: BZD
Recalls: 1 (1 Class I)
Predicates: 4

Its longest line of descent runs back 3 generations to K833786 (1983). 8 ancestors in all. 4 later devices descend from it, 3 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
2 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
1 generation backK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
This deviceK063268 Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007
Descendant · cites it directly · 1 of its ownK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
Descendant · 2 generations on · 0 of its ownK243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask -…Genadyne Biotechnologies, Inc. · 2024
Descendant · cites it directly · 0 of its ownK102120 Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone…Hsiner Co., Ltd. · 2011
Descendant · cites it directly · 0 of its ownK072755 Galemed Cpap MaskGalemed Corp. · 2007

Most influential descendants

Showing 4 of 4 · See all

K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company · 2012 · cites it directly1descendant
K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc. · 2024 · 2 generations on0descendants
K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd. · 2011 · cites it directly0descendants
K072755Galemed Cpap MaskGalemed Corp. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K833786	Microprocessor Ventilator 7200	Puritan Bennett Corp.	1983	—
−2	K951264	Bipap Model S/T-D	Respironics, Inc.	1996	—
−1	K991648	Reusable Contour II Nasal Mask	Respironics, Inc.	1999	—
0 (this device)	K063268	Cpap/Vpap Masks, Models 1225, 1205 and 1235	Hsiner Co., Ltd.	2007	—
+1	K120920	Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner…	Hsiner Company	2012	—
+2	K243225	Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium…	Genadyne Biotechnologies, Inc.	2024	—
+1	K102120	Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask…	Hsiner Co., Ltd.	2011	—
+1	K072755	Galemed Cpap Mask	Galemed Corp.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1995	1	0
1996	1	0
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	1	0
2012	1	0
2024	1	0

FIG. 1 — Lineage of K063268, 1983–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZD device

#1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K002465	Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 Summary page 1 …Regulation Number: 868.5905 Device Class 2 8.3. Substantially equivalent to: * Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915) * Respironics Comfort Select Nasal CPAP Mask (KO000705, K99 1648) 8.4. Description of the device The Hsin…	Respironics, Inc.	2000	—
*	K961915	Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large Summary page 1 …Regulation Number: 868.5905 Device Class 2 8.3. Substantially equivalent to: * Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915) * Respironics Comfort Select Nasal CPAP Mask (KO000705, K99 1648) 8.4. Description of the device The Hsiner CPAP/V…	Respironics, Inc.	1996	—
*	K000705	Respironics Silhouette Nasal Mask, Models 1003224 and 1003223 Summary page 1 …8.3. Substantially equivalent to: * Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915) * Respironics Comfort Select Nasal CPAP Mask (KO000705, K99 1648) 8.4. Description of the device The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both…	Respironics, Inc.	2000	—
*	K991648	Reusable Contour II Nasal Mask Summary page 1 …Substantially equivalent to: * Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915) * Respironics Comfort Select Nasal CPAP Mask (KO000705, K99 1648) 8.4. Description of the device The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homeca…	Respironics, Inc.	1999	—

Also cleared against K002465: 9 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120920	Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…	Hsiner Company	2012	1
K102120	Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…	Hsiner Co., Ltd.	2011	0
K072755	Galemed Cpap Mask	Galemed Corp.	2007	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 18, 2018	Class I	Z-2741-2018	Component change control	A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K120920 (Hsiner Company, 2012) has gone furthest, with 1 descendant of its own.
9 other devices also cite its predicate K002465.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	21	83	29	65
2008	17	108	2	67
2009	23	90	1	147
2010	12	122	0	143
2011	23	125	1	189
2012	21	133	0	139
2013	23	127	0	82
2014	14	172	0	86
2015	11	224	0	114
2016	12	217	0	118
2017	5	221	0	148
2018	5	280	0	101
2019	6	231	4 (4)	188
2020	6	137	0	126
2021	6	192	0	6,066
2022	4	253	0	90,768
2023	5	204	8 (7)	27,987
2024	10	132	0	68,262
2025	7	189	0	60,279
2026	10	214	2 (2)	—

What is it indicated for?

The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063268 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063268

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026