510(k) · Cleared
ClearedSarns Ultrasonic Air Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Health Care, Sarns · KRL Detector, Bubble, Cardiopulmonary Bypass
Cleared on May 24, 1994 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 24, 1994
- Review
- 98 days
- Class
- Class II
- Product code
- KRL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK940651 Sarns Ultrasonic Air Sensor3M Health Care, Sarns · 1994
- Descendant · cites it directly · 5 of its ownK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · 3 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- Descendant · 4 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
- Descendant · 5 generations on · 1 of its ownK202733 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091908M3 MonitorSpectrum Medical, Ltd. · 2009 · cites it directly5descendants
- K110957M4 MonitorSpectrum Medical, Llp · 2011 · 2 generations on4descendants
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 3 generations on3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 4 generations on2descendants
- K202733Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2020 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940651 | Sarns Ultrasonic Air Sensor | 3M Health Care, Sarns | 1994 | — |
| +1 | K091908 | M3 Monitor | Spectrum Medical, Ltd. | 2009 | 1 |
| +2 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +3 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| +4 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
| +5 | K202733 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K091908 (Spectrum Medical, Ltd., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KRL devicesKRL Detector, Bubble, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRL
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KRL
Too few KRL 510(k)s in any year since 2007 to give a median.
Recalls per year · KRL
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRL
4in 2024
MAUDE reports naming product code KRL, 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 | 1 | — | 3 | 10 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K940651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940651: Sarns Ultrasonic Air Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940651
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026