510(k) · Cleared
ClearedCare ZY5BA Oxygen Concentrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Care Medical Technology Co., Ltd. · CAW Generator, Oxygen, Portable
Cleared on Nov 9, 2010 as substantially equivalent to K071608 (Zhongshan A&J Medical Equipment Co., Ltd., 2008) after a 92-day review. Its family tree reaches back 3 generations to 1988. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 9, 2010
- Review
- 92 days
- Class
- Class II
- Product code
- CAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883591 (1988). 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 backK883591 Mark-5 ConcentratorNidek Medical Products, Inc. · 1988
- 2 generations backK032509 Mark 5 Nuvo (M5C5)Nidek Medical Products, Inc. · 2004 · Recalled (Class I)
- 1 generation backK071608 A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd. · 2008
- This deviceK102245 Care ZY5BA Oxygen ConcentratorFoshan Care Medical Technology Co., Ltd. · 2010
Class I recalls in this family
- K032509 Mark 5 Nuvo (M5C5)2 generations back · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883591 | Mark-5 Concentrator | Nidek Medical Products, Inc. | 1988 | — |
| −2 | K032509 | Mark 5 Nuvo (M5C5) | Nidek Medical Products, Inc. | 2004 | Class I |
| −1 | K071608 | A&J POCA01 Oxygen Concentrator | Zhongshan A&J Medical Equipment Co., Ltd. | 2008 | — |
| 0 (this device) | K102245 | Care ZY5BA Oxygen Concentrator | Foshan Care Medical Technology Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 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 CAW device
- #1 K230052 Inogen Rove 6score 29.9 · 2 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 |
|---|---|---|---|
| * | K071608 | A&J POCA01 Oxygen ConcentratorSummary page 1…51BA Oxygen Concentrator Common Name: Oxygen Concentrator Classification: Class II as per 21 CFR 868.5440, Portable Oxygen Generator Legally Marketed Predicate Device: K07 1608 A&J-POCAO I Oxygen Concentrator Intended Use: Ch… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K032509Mark 5 Nuvo (M5C5)Nidek Medical Products, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K071608.
How does its category compare?
All CAW devicesCAW Generator, Oxygen, Portable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CAW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAW
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · CAW
611in 2025
MAUDE reports naming product code CAW, 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 | 6 | 143 | 1 | 23 |
| 2008 | 11 | 90 | 3 | 25 |
| 2009 | 8 | 193 | 2 | 43 |
| 2010 | 5 | 133 | 0 | 48 |
| 2011 | 6 | 174 | 1 | 167 |
| 2012 | 5 | 148 | 0 | 395 |
| 2013 | 2 | — | 2 | 2,309 |
| 2014 | 6 | 277 | 2 | 24,538 |
| 2015 | 1 | — | 0 | 18,973 |
| 2016 | 1 | — | 1 | 3,167 |
| 2017 | 1 | — | 1 | 107 |
| 2018 | 3 | 203 | 0 | 116 |
| 2019 | 2 | — | 2 | 120 |
| 2020 | 5 | 224 | 1 | 125 |
| 2021 | 2 | — | 0 | 194 |
| 2022 | 4 | 458 | 2 | 305 |
| 2023 | 8 | 261 | 0 | 357 |
| 2024 | 2 | — | 5 (1) | 450 |
| 2025 | 12 | 178 | 1 | 611 |
| 2026 | 6 | 260 | 0 | — |
What is it indicated for?
The CARE ZY51BA Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The CARE ZY5BA Oxygen Concentrator is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102245: Care ZY5BA Oxygen Concentrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102245
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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