510(k) · Cleared
Recalled · Class I · 2023Seattle - Pap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seattle Childrens Hospital · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 11, 2013 as substantially equivalent to K100011 (Fisher & Paykel Healthcare, Ltd., 2010) after a 140-day review. Its family tree reaches back 3 generations to 1991. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 11, 2013
- Review
- 140 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902859 (1991). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK974176 Babylog 8000 PlusDrager, Inc. · 1998 · Recalled
- 1 generation backK100011 Fisher & Paykel Healthcare Bubble Cpap SystemFisher & Paykel Healthcare, Ltd. · 2010
- This deviceK131502 Seattle - PapSeattle Childrens Hospital · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | 1 |
| −1 | K100011 | Fisher & Paykel Healthcare Bubble Cpap System | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| 0 (this device) | K131502 | Seattle - Pap | Seattle Childrens Hospital | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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.
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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K100011 | Fisher & Paykel Healthcare Bubble Cpap SystemSummary page 2…Proposed device Predicate 51 O~k) K1000 11 Manufacturer Fisher & Paykel Device Name… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2023 | Class I | Z-1439-2023 | Process control | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100011.
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 Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician.
It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131502: Seattle - Pap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131502
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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