510(k) · Cleared
ClearedLactate Pro System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kdk Corp. · KHP Acid, Lactic, Enzymatic Method
Cleared on Sep 11, 1998 as substantially equivalent to K951331 (Boehringer Mannheim Corp., 1995) and 1 other predicate after a 185-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Sep 11, 1998
- Review
- 185 days
- Class
- Class I
- Product code
- KHP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913806 (1991). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913806 Ysi Model 2300 Stat PlusYsis, Inc. · 1991
- This deviceK980908 Lactate Pro SystemKdk Corp. · 1998
- Descendant · cites it directly · 1 of its ownK100602 Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test…Nova Biomedical Corp. · 2011
- Descendant · 2 generations on · 0 of its ownK112955 Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913806 | Ysi Model 2300 Stat Plus | Ysis, Inc. | 1991 | — |
| 0 (this device) | K980908 | Lactate Pro System | Kdk Corp. | 1998 | — |
| +1 | K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips | Nova Biomedical Corp. | 2011 | — |
| +2 | K112955 | Nova Statstrip Lactate Hospital Meter System | Nova Biomedical Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 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? (2)
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 |
|---|---|---|---|
| * | K951331 | Accusport Lactate Monitoring System Lactate Test Strips Accusport MonitorSummary page 4…ablish a proper intensity of exercise for athletes. The system can beusedin the home and in‘the clinical setfing. (Predicate Devices) Boehringer Mannheim ACCUSPORT No. K951331 YSI INC. YSIMODEL 2300 STAT PLUS No. K913806 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . < Conc… | 1995 |
| * | K913806 | Ysi Model 2300 Stat PlusSummary page 4…etes. The system can beusedin the home and in‘the clinical setfing. (Predicate Devices) Boehringer Mannheim ACCUSPORT No. K951331 YSI INC. YSIMODEL 2300 STAT PLUS No. K913806 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . < Concurrence of CDRH, Office of Device Evaluation (… | 1991 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100602 | Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test Strips | 2011 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K100602 (Nova Biomedical Corp., 2011) has gone furthest, with 1 descendant of its own.
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 Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the home and in the clinical setfing.
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/K980908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980908: Lactate Pro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980908
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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