510(k) · Cleared
ClearedCrit-Scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noninvasive Medical Technology Corp. · DQA Oximeter
Cleared on Jun 2, 1992 after a 510-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 2, 1992
- Review
- 510 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK910077 Crit-ScanNoninvasive Medical Technology Corp. · 1992
- Descendant · cites it directly · 2 of its ownK091564 NBM-200MP Pulse Oximetry DeviceOrsense, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK124041 NBM-200MPOrsense, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK142209 Pulse oximeter NBM-200Orsense, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK983551 Crit-Scan II MonitorIn-Line Diagnostics Corp. · 1999
Most influential descendants
Showing 4 of 4 · See all- K091564NBM-200MP Pulse Oximetry DeviceOrsense, Ltd. · 2010 · cites it directly2descendants
- K124041NBM-200MPOrsense, Ltd. · 2013 · 2 generations on1descendant
- K142209Pulse oximeter NBM-200Orsense, Ltd. · 2015 · 3 generations on0descendants
- K983551Crit-Scan II MonitorIn-Line Diagnostics Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910077 | Crit-Scan | Noninvasive Medical Technology Corp. | 1992 | — |
| +1 | K091564 | NBM-200MP Pulse Oximetry Device | Orsense, Ltd. | 2010 | — |
| +2 | K124041 | NBM-200MP | Orsense, Ltd. | 2013 | — |
| +3 | K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015 | — |
| +1 | K983551 | Crit-Scan II Monitor | In-Line Diagnostics Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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, K091564 (Orsense, Ltd., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K910077 · printed Nov 5, 2026
Cite this page
510(k) Report. “K910077: Crit-Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K910077
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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