510(k) · Cleared
ClearedCerOX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Or-Nim Medical, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Nov 6, 2015 as substantially equivalent to K131854 (Or-Nim Medical, Ltd., 2013) and 1 other predicate after a 275-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Nov 6, 2015
- Review
- 275 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K931154 (1993). 48 ancestors in all, the oldest K850978 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations between
- 3 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010
- 1 generation backK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
- This deviceK150268 CerOXOr-Nim Medical, Ltd. · 2015
Show all 12 generations
- Root · 12 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 11 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 10 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 9 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 8 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 7 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 6 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 5 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 4 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 3 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 2 generations backK094030 Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series…Cas Medical Systems, Inc. · 2010
- 1 generation backK112820 Fore-Sight Absolute Tissue OximeterCas Medical Systems, Inc. · 2012
- This deviceK150268 CerOXOr-Nim Medical, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −11 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −10 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −9 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −8 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −7 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −6 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −4 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −3 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −2 | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models… | Cas Medical Systems, Inc. | 2010 | — |
| −1 | K112820 | Fore-Sight Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K150268 | CerOX | Or-Nim Medical, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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.
Planning a device in DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K131854 | CEROXSummary page 4…Regulatory II Class: Predicate Devices: - CerOx 3210FO, Or-Nim Medical Ltd. (K131854) - Fore-Sight Absolute Tissue Oximeter, CAS MED (K112820)… | 2013 |
| * | K112820 | Fore-Sight Absolute Tissue OximeterSummary page 4…Class: Predicate Devices: - CerOx 3210FO, Or-Nim Medical Ltd. (K131854) - Fore-Sight Absolute Tissue Oximeter, CAS MED (K112820) K150268… | 2012 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 48 ancestors have a recall of any class.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The non-invasive CerOx 3215FOP monitor is intended for use as an adjunct monitor of
microcirculation blood flow in tissue.
The CerOx3215FOP monitor is intended for monitoring of newborn - adult.
The prospective clinical value of data from the CerOx 3215FOP monitor has not been
demonstrated in disease states. The CerOx 3215FOP monitor should not be used as the
sole basis for diagnosis or therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150268 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150268: CerOX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150268
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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