510(k) · Cleared
ClearedRaichem CO2 Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reagents Applications, Inc. · KHS Enzymatic, Carbon-Dioxide
Cleared on Jun 24, 1998 as substantially equivalent to K854544 (Reagents Applications, Inc., 1985) after a 15-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Jun 24, 1998
- Review
- 15 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854544 (1985). No later device cites it as a predicate yet.
- Root · 1 generation backK854544 Raichem CO2 ReagentReagents Applications, Inc. · 1985
- This deviceK982056 Raichem CO2 ReagentReagents Applications, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854544 | Raichem CO2 Reagent | Reagents Applications, Inc. | 1985 | — |
| 0 (this device) | K982056 | Raichem CO2 Reagent | Reagents Applications, Inc. | 1998 | — |
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 KHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K854544 | Raichem CO2 ReagentSummary page 1…dioxide Test System Device Classification: |l Regulation Number: 21 CFR 862.1160 Panel: Chemistry (75) CDT Predicate (Cleared) Device CO, Reagent: 510(k) Docket No. K854544 Manufactured By: Raichem Division of Hemagen Diagnostics Inc. (Reagents : Applications, Inc.) Submitted By: Reagents Applicati… | 1985 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The use of this reagent is indicated for the measurement of CO2 levels in serum or plasma on manual or automated systems. The measurement of serum or plasma CO2 content is useful in the assessment of disturbance of acid base balance in respiratory or metabolic acidosis and alkalosis
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/K982056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982056: Raichem CO2 Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982056
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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