510(k) · Cleared
ClearedTranscend Auto
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnetics International, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 17, 2013 as substantially equivalent to K100121 (Aeiomed, Inc., 2010) and 1 other predicate after a 99-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Oct 17, 2013
- Review
- 99 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K903764 (1990). 35 ancestors in all, the oldest K900164 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 7 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 6 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 5 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 4 generations backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- 3 generations backK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- 2 generations backK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- 1 generation backK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- This deviceK132127 Transcend AutoSomnetics International, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −7 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −6 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −5 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −4 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| −3 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| −2 | K042945 | Aura Cpap System | Aeiomed, Inc. | 2005 | — |
| −1 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| 0 (this device) | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +1 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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.
Planning a device in BZD? 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K100121 | Model 300157 Cpap SystemSummary page 1…Product Code BZD Predicate Devices Somnetics International, Inc., Model 300157 CPAP System (K100121) IRespironics REMstar Auto CPAP with C-Flex (K041010) Device Description The Transcend Auto… | 2010 |
| * | K041010 | Remstar Auto with C-Flex Cpap SystemSummary page 1…ernational, Inc., Model 300157 CPAP System (K100121) IRespironics REMstar Auto CPAP with C-Flex (K041010) Device Description The Transcend Auto is a microprocessor-control led, blower-based system that generates positive airway press… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180388 | Transcend 365 miniCPAP System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K180388 (Somnetics International, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K100121.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 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 Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132127 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132127: Transcend Auto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132127
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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