510(k) · Cleared
ClearedCiba Corning 348 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 Jun 24, 1996 as substantially equivalent to K933373 (Ciba Corning Diagnostics Corp., 1993) after a 32-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Jun 24, 1996
- Review
- 32 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933373 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK933373 Ciba Corning 300 Series SystemCiba Corning Diagnostics Corp. · 1993
- This deviceK962021 Ciba Corning 348 SystemCiba Corning Diagnostics Corp. · 1996
- Descendant · cites it directly · 0 of its ownK033060 Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933373 | Ciba Corning 300 Series System | Ciba Corning Diagnostics Corp. | 1993 | — |
| 0 (this device) | K962021 | Ciba Corning 348 System | Ciba Corning Diagnostics Corp. | 1996 | — |
| +1 | K033060 | Calibrating Material, Calibrating Standards | Diamond Diagnostics, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (1)
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 |
|---|---|---|---|
| * | K933373 | Ciba Corning 300 Series SystemSummary page 1…62.1120, Class Il pH - 21 CFR 862.1120, Class 1. Predicate Device Information ‘Name: Model 850 Analyzer Manufacturer: Ciba Corning Diagnostics Corp. 510(k) Number: D.C. #K933373 2. Device Description The 348 Series system analyzer is a point of care and laboratory testing analyzer used for the direct measu… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033060 | Calibrating Material, Calibrating Standards | 2004 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K033060 (Diamond Diagnostics, Inc., 2004) has gone furthest, with 0 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 Ciba Corning 348 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962021 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962021: Ciba Corning 348 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962021
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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