510(k) · Cleared
Recalled · 2004Avl 9110PH Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avl Scientific Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Oct 14, 1993 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 7 times.
- Decided
- Oct 14, 1993
- Review
- 134 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 7
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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
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- #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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2004 | Not classified | Z-0608-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0610-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0605-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0606-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0607-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0611-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
| Dec 21, 2004 | Not classified | Z-0609-05 | Other | A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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/K932642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932642: Avl 9110PH Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932642
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026