510(k) · Cleared
Cleared860 Measurment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Corning Diagnostics Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jan 3, 1994 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jan 3, 1994
- Review
- 80 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK934907 860 Measurment SystemCiba Corning Diagnostics Corp. · 1994
- Descendant · cites it directly · 1 of its ownK031560 Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK113216 Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK101947 IVD-GE02Sphere Medical, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK973742 Sendx 100 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK961657 Ciba Corning 400 SystemCiba Corning Diagnostics Corp. · 1996
Most influential descendants
Showing 5 of 5 · See all- K031560Bayer Rapidlab 1200 SystemBayer Healthcare, LLC · 2003 · cites it directly1descendant
- K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 2012 · 2 generations on0descendants
- K101947IVD-GE02Sphere Medical, Ltd. · 2011 · cites it directly0descendants
- K973742Sendx 100 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 1997 · cites it directly0descendants
- K961657Ciba Corning 400 SystemCiba Corning Diagnostics Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934907 | 860 Measurment System | Ciba Corning Diagnostics Corp. | 1994 | — |
| +1 | K031560 | Bayer Rapidlab 1200 System | Bayer Healthcare, LLC | 2003 | 14 |
| +2 | K113216 | Rapidpoint 500 Blood Gas Analyer | Siemens Healthcare Diagnostics | 2012 | 12 |
| +1 | K101947 | IVD-GE02 | Sphere Medical, Ltd. | 2011 | — |
| +1 | K973742 | Sendx 100 PH, Blood Gas and Electrolyte Analysis System | Sendx Medical, Inc. | 1997 | — |
| +1 | K961657 | Ciba Corning 400 System | Ciba Corning Diagnostics Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
4 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, K031560 (Bayer Healthcare, LLC, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
https://510kreport.com/device/K934907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934907: 860 Measurment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934907
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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