510(k) Report

510(k) · Cleared

Cleared

Single Vial Lactate

K780563510(k) TraditionalCleared Apr 18, 197811-day reviewClass II21 CFR 862.1440

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

Boehringer Mannheim Corp. · CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Cleared on Apr 18, 1978 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 18, 1978
Review
11 days
Class
Class II
Product code
CFJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2006: 1 descendant cleared19801990200020102020
  1. This deviceK780563 Single Vial LactateBoehringer Mannheim Corp. · 1978
  2. Descendant · cites it directly · 1 of its ownK964457 Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK060853 Online TDM TobramycinRoche Diagnostics Corp. · 2006 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997 · cites it directly1descendant
  • K060853Online TDM TobramycinRoche Diagnostics Corp. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K780563Single Vial LactateBoehringer Mannheim Corp.1978—
+1K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.19972
+2K060853Online TDM TobramycinRoche Diagnostics Corp.20062

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
FIG. 1 — Lineage of K780563, 1978–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 CFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.19971

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, K964457 (Roche Diagnostic Systems, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CFJ devices

CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFJ

1in 2013

2009: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CFJ

Too few CFJ 510(k)s in any year since 2007 to give a median.

Recalls per year · CFJ

1in 2018

2013: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · CFJ

12in 2025

2010: 42011: 32012: 12016: 42017: 152018: 102019: 182020: 102021: 102022: 82023: 32024: 102025: 12
2007high 18 (2019) · low 0 (2007)2025

MAUDE reports naming product code CFJ, 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
20091—00
20100—04
20110—03
20120—01
20131—10
20140—00
20150—00
20160—04
20170—015
20180—110
20190—018
20200—010
20210—010
20220—08
20230—03
20240—010
20250—012
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 CFJ

The CFJ category page

  • K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L ReagentAlfa Wassermann Diagnostic Technologies, Inc. · 2013
  • K091544S-Test Lactate Dehydrogenase (LD), Model RC 0017Alfa Wassermann, Inc. · 2009
  • K051108Piccolo Lactate Dephydrogenase Test SystemAbaxis, Inc. · 2005
  • K974859Lactane Dehydrogenase-SL Assay, Catalogue Number 327-10, 327-30Diagnostic Chemicals, Ltd. · 1998
  • K973589Liquid LDH-L Reagent SetPointe Scientific, Inc., · 19971 recall

https://510kreport.com/device/K780563 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780563: Single Vial Lactate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780563

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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