510(k) · Cleared
ClearedIrma SL Blood Analysis System Lactate Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diametrics Medical, Inc. · KHP Acid, Lactic, Enzymatic Method
Cleared on Jan 28, 2002 as substantially equivalent to K891480 (Yellow Springs Instrument Co., Inc., 1989) after a 61-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jan 28, 2002
- Review
- 61 days
- Class
- Class I
- Product code
- KHP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891480 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891480 Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerYellow Springs Instrument Co., Inc. · 1989
- This deviceK013938 Irma SL Blood Analysis System Lactate CartridgeDiametrics Medical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891480 | Ysi Model 2300 Stat Glucose and L-Lactate Analyzer | Yellow Springs Instrument Co., Inc. | 1989 | — |
| 0 (this device) | K013938 | Irma SL Blood Analysis System Lactate Cartridge | Diametrics Medical, Inc. | 2002 | — |
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 KHP? 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 |
|---|---|---|---|
| * | K891480 | Ysi Model 2300 Stat Glucose and L-Lactate AnalyzerSummary page 1…lood Analysis System Lactate Cartridge Lactic Acid Test System Acid, Lactic, Enzymatic Method Class I 21 CFR 862.1450 Chemistry (75) KHP YSI Model 2300 Stat Plus. K891480 75 CGA The IRMA® SL Blood Analysis System GL Cartridge is substantially equivalent in method, intended use and clinical perform… | 1989 |
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.
- 2 other devices also cite its predicate K891480.
How does its category compare?
All KHP devicesKHP Acid, Lactic, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHP
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · KHP
Too few KHP 510(k)s in any year since 2007 to give a median.
Recalls per year · KHP
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHP
9in 2025
MAUDE reports naming product code KHP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 12 |
| 2014 | 0 | — | 1 | 19 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 3 | 41 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The lactate sensor is intended for professional and point of care use with the IRMA® Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
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/K013938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013938: Irma SL Blood Analysis System Lactate Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013938
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026