510(k) Report

510(k) · Cleared

Cleared

Behring Nephelometer System

K860894510(k) TraditionalCleared Apr 15, 198636-day reviewClass II21 CFR 866.5510

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

Behring Diagnostics, Inc. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)

Cleared on Apr 15, 1986 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 44 later devices descend from it.

Decided
Apr 15, 1986
Review
36 days
Class
Class II
Product code
CFN
Recalls
None
Predicates
0

44 later devices descend from it, 17 citing it directly.

Descendants, by year cleared 2007: 7 descendants cleared1997: 1 descendant cleared2005: 4 descendants cleared2004: 3 descendants cleared1996: 3 descendants cleared2006: 9 descendants cleared2001: 2 descendants cleared2008: 4 descendants cleared2009: 2 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared1999: 3 descendants cleared1998: 1 descendant cleared2023: 1 descendant cleared2002: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
  2. Descendant · cites it directly · 10 of its ownK042735 N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc. · 2005
  3. Descendant · cites it directly · 8 of its ownK053072 N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc. · 2006
  4. Descendant · 2 generations on · 7 of its ownK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
  5. Descendant · cites it directly · 7 of its ownK962523 N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996
  6. Descendant · 2 generations on · 6 of its ownK063663 Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

1996: 31997: 11998: 11999: 32001: 22002: 12004: 32005: 42006: 92007: 72008: 42009: 22017: 12018: 12019: 12023: 1
1996high 9 (2006) · low 0 (2000)2026

Most influential descendants

Showing 5 of 44 · See all
  • K042735N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc. · 2005 · cites it directly10descendants
  • K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc. · 2006 · cites it directly8descendants
  • K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006 · 2 generations on7descendants
  • K962523N Latex CRP Mono ReagentBehring Diagnostics, Inc. · 1996 · cites it directly7descendants
  • K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc. · 2007 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860894Behring Nephelometer SystemBehring Diagnostics, Inc.1986—
+1K042735N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc.2005—
+1K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc.2006—
+2K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.2006—
+1K962523N Latex CRP Mono ReagentBehring Diagnostics, Inc.1996—
+2K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and…Dade Behring, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199710
199810
199930
200120
200210
200430
200540
200690
200770
200840
200920
201710
201810
201910
202310
FIG. 1 — Lineage of K860894, 1986–2023Source: 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 CFN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CFN device

  1. #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (44)

See all 44

17 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042735N Antisera to Human Immunoglobulins (Igg, Iga and Igm)Dade Behring, Inc.200510
K053072N Antisera to Human ALPHA1-AntitrypsinDade Behring, Inc.20068
K962523N Latex CRP Mono ReagentBehring Diagnostics, Inc.19967
K061990Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…Dade Behring, Inc.20066
K053074N Antisera to Human CeruloplasminDade Behring, Inc.20062
K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Dade Behring, Inc.20071
K053073N Antisera to Human ALPHA2-MacroglobulinDade Behring, Inc.20061
K050665N Antisera to Human Complement Factors (C3C, C4)Dade Behring, Inc.20051
K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.19971
K961824Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinRoche Diagnostic Systems, Inc.19961

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, K042735 (Dade Behring, Inc., 2005) has gone furthest, with 10 descendants of its own.

How does its category compare?

All CFN devices

CFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CFN

2in 2023

2008: 72009: 42010: 22012: 12013: 42014: 22015: 12017: 12019: 62023: 2
2007high 7 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CFN

28in 2019

2008: 69 days median2009: 160 days median2013: 431 days median2019: 28 days median
2007high 431 (2013) · low 28 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CFN

1in 2023

2014: 52018: 22022: 22023: 1
2007high 5 (2014) · low 0 (2007)2026

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

Adverse event reports per year · CFN

1in 2024

2010: 32012: 32016: 22017: 42018: 22019: 82022: 12024: 1
2007high 8 (2019) · low 0 (2007)2025

MAUDE reports naming product code CFN, 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
200876900
2009416000
20102—03
20110—00
20121—03
2013443100
20142—50
20151—00
20160—02
20171—04
20180—22
201962808
20200—00
20210—00
20220—21
20232—10
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 CFN

The CFN category page

  • K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH · 2023
  • K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
  • K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group, Ltd. · 2019
  • K191985Optilite IgA KitThe Binding Site Group, Ltd. · 2019
  • K191635Optilite IgM KitThe Binding Site Group, Ltd. · 20191 recall

https://510kreport.com/device/K860894 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860894: Behring Nephelometer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860894

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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