510(k) · Cleared
ClearedPulse Oximeter Model AB-F1/AH-S1/AH-M1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acare Technology Co., Ltd. · DQA Oximeter
Cleared on Dec 22, 2011 after a 195-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 22, 2011
- Review
- 195 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
Finger Type Pulse Oximeter, AB-F I is indicated for spot checking of functional arterial oxygen saturation (SpO 2 ) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult patients use. Handheld Pulse Oximeter, AH-S I is indicated for spot checking of functional arterial oxygen saturation (SpO 2 ) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It…
Read the full statement (128 words)
Finger Type Pulse Oximeter, AB-F I is indicated for spot checking of functional arterial oxygen saturation (SpO 2 ) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult patients use.
Handheld Pulse Oximeter, AH-S I is indicated for spot checking of functional arterial oxygen saturation (SpO 2 ) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
Handhield Pulse Oximeter, AH-M I is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K111617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111617: Pulse Oximeter Model AB-F1/AH-S1/AH-M1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111617
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026