510(k) Report

510(k) · Cleared

Cleared

Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor

K951331510(k) TraditionalCleared Aug 11, 1995140-day reviewClass I21 CFR 862.1450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boehringer Mannheim Corp. · KHP Acid, Lactic, Enzymatic Method

Cleared on Aug 11, 1995 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Aug 11, 1995
Review
140 days
Class
Class I
Product code
KHP
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951331 Accusport Lactate Monitoring System Lactate Test Strips Accusport…Boehringer Mannheim Corp. · 1995
  2. Descendant · cites it directly · 2 of its ownK980908 Lactate Pro SystemKdk Corp. · 1998
  3. Descendant · 2 generations on · 1 of its ownK100602 Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test…Nova Biomedical Corp. · 2011
  4. Descendant · 3 generations on · 0 of its ownK112955 Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K980908Lactate Pro SystemKdk Corp. · 1998 · cites it directly2descendants
  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011 · 2 generations on1descendant
  • K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951331Accusport Lactate Monitoring System Lactate Test Strips Accusport MonitorBoehringer Mannheim Corp.1995—
+1K980908Lactate Pro SystemKdk Corp.1998—
+2K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp.2011—
+3K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201110
201210
FIG. 1 — Lineage of K951331, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980908Lactate Pro SystemKdk Corp.19982

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?

  • Of its descendants, K980908 (Kdk Corp., 1998) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KHP devices

KHP Acid, Lactic, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KHP

1in 2013

2010: 12011: 22012: 22013: 1
2007high 2 (2011) · low 0 (2007)2026

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

2014: 12016: 3
2007high 3 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KHP

9in 2025

2010: 22011: 22012: 32013: 122014: 192015: 122016: 412017: 92018: 122019: 102020: 62021: 32022: 72023: 32024: 132025: 9
2007high 41 (2016) · low 0 (2007)2025

MAUDE reports naming product code KHP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—02
20112—02
20122—03
20131—012
20140—119
20150—012
20160—341
20170—09
20180—012
20190—010
20200—06
20210—03
20220—07
20230—03
20240—013
20250—09
20260—0—

More from Boehringer Mannheim Corp.

345 FDA decisions under this applicant name. See the company

  • K984326Elecys Ige AssayBoehringer Mannheim Corp. · 1999
  • K983047Accu-Chek HQ SystemBoehringer Mannheim Corp. · 19991 recall
  • K984419Elecsys Ige CalcheckBoehringer Mannheim Corp. · 1999
  • K984425Modification of Preciset Serum Proteins CalibratorBoehringer Mannheim Corp. · 1999
  • K984372Elecsys Calcheck Troponin TBoehringer Mannheim Corp. · 1998

Recent decisions in KHP

The KHP category page

  • K130113Piccolo Lactate Test SystemAbaxis, Inc. · 2013
  • K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 201212 recalls
  • K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012
  • K112430I-Stat Lactate Test/I-Sat CG4+CartridgeAbbott Pont of Care, Inc. · 2011
  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011

https://510kreport.com/device/K951331 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951331: Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951331

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026