510(k) Report

510(k) · Cleared

Cleared

Batroxobin Reagent

K932787510(k) TraditionalCleared Nov 29, 1993173-day reviewClass II21 CFR 864.8100

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

Behring Diagnostics, Inc. · JCO Bothrops Atrox Reagent

Cleared on Nov 29, 1993 after a 173-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 29, 1993
Review
173 days
Class
Class II
Product code
JCO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K932787Source: FDA 510(k) database · 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 JCO? 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?

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.

How does its category compare?

All JCO devices

JCO Bothrops Atrox Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCO

FDA has decided no JCO device since 2007.

Median 510(k) review, days · JCO

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

Recalls per year · JCO

No recall names JCO since 2007.

Adverse event reports per year · JCO

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code JCO, 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
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

More from Behring Diagnostics, Inc.

146 FDA decisions under this applicant name. See the company

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997

Recent decisions in JCO

The JCO category page

  • K955115Venom Tiem ReagentMedical Diagnostic Technologies, Inc. · 1996
  • K896033FDP Collection TubesMedical Diagnostic Technologies, Inc. · 1989
  • K852519Dupont Aca Fibrin Degradation Prod Clotting TubeE.I. Dupont DE Nemours & Co., Inc. · 1985
  • K843207Reptilase -PCBio/Data Corp. · 1984
  • K840210Reptilase-R HA35Wellcome Diagnostics · 1984

https://510kreport.com/device/K932787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932787: Batroxobin Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932787

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