510(k) · Cleared
Recalled · 2007Abl 77 PH, Blood Gas and Electrolyte Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sendx Medical, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Feb 1, 2000 after a 40-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2000
- Review
- 40 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK994346 Abl 77 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK051804 ABL80 Flex AnalyzerSendx Medical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 1 of its ownK080370 Abl 80 CO-OX SystemSendx Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK151856 ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc. · 2015 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994346 | Abl 77 PH, Blood Gas and Electrolyte Analysis System | Sendx Medical, Inc. | 2000 | — |
| +1 | K051804 | ABL80 Flex Analyzer | Sendx Medical, Inc. | 2005 | 4 |
| +2 | K080370 | Abl 80 CO-OX System | Sendx Medical, Inc. | 2008 | 4 |
| +3 | K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | 2015 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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 14.2 · 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051804 | ABL80 Flex Analyzer | 2005 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2007 | Not classified | Z-1173-2007 | Other | Error in the Ca12 calibration value for pCO2 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pCO2 results at the high end of the measuring range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051804 (Sendx Medical, Inc., 2005) has gone furthest, with 2 descendants 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 | — |
What is it indicated for?
The ABL 77 pH, Blood Gas and Electrolyte Analysis System is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The ABL 77 pH, Blood Gas and Electrolyte Analysis System can be used in the laboratory, near patient, or point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial and venous whole blood samples.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994346: Abl 77 PH, Blood Gas and Electrolyte Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994346
Report an extraction error
Are you the manufacturer?
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