510(k) Report

510(k) · Cleared

Cleared

Behring Nephelometer II

K943997510(k) TraditionalCleared Oct 3, 199448-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. · DEW Igg, Antigen, Antiserum, Control

Cleared on Oct 3, 1994 after a 48-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.

Decided
Oct 3, 1994
Review
48 days
Class
Class II
Product code
DEW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK943997 Behring Nephelometer IIBehring Diagnostics, Inc. · 1994
  2. Descendant · cites it directly · 4 of its ownK050113 Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
  3. Descendant · 2 generations on · 3 of its ownK073490 Olympus Igg ReagentOlympus America, Inc. · 2008
  4. Descendant · 3 generations on · 1 of its ownK162208 DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017
  5. Descendant · 4 generations on · 0 of its ownK221114 Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023
  6. Descendant · 3 generations on · 0 of its ownK193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G…Horiba Abx Sas · 2020

Most influential descendants

Showing 5 of 5 · See all
  • K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005 · cites it directly4descendants
  • K073490Olympus Igg ReagentOlympus America, Inc. · 2008 · 2 generations on3descendants
  • K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc. · 2017 · 3 generations on1descendant
  • K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · 2023 · 4 generations on0descendants
  • K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943997Behring Nephelometer IIBehring Diagnostics, Inc.1994—
+1K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp.2005—
+2K073490Olympus Igg ReagentOlympus America, Inc.2008—
+3K162208DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentBeckman Coulter, Inc.2017—
+4K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.2023—
+3K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…Horiba Abx Sas2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201710
202010
202310
FIG. 1 — Lineage of K943997, 1994–2023Source: 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 DEW? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp.20054

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, K050113 (Roche Diagnostics Corp., 2005) has gone furthest, with 4 descendants of its own.

How does its category compare?

All DEW devices

DEW Igg, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DEW

FDA has decided no DEW device since 2007.

Median 510(k) review, days · DEW

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

Recalls per year · DEW

1in 2024

2010: 12024: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DEW

4in 2024

2009: 42010: 22011: 162015: 22016: 42017: 62018: 12019: 92020: 192023: 12024: 4
2007high 19 (2020) · low 0 (2007)2025

MAUDE reports naming product code DEW, 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—04
20100—12
20110—016
20120—00
20130—00
20140—00
20150—02
20160—04
20170—06
20180—01
20190—09
20200—019
20210—00
20220—00
20230—01
20240—14
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 DEW

The DEW category page

  • K050113Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2005
  • K040434Roche Diagnostics Tina-Quant Igg Gen.2Roche Diagnostics Corp. · 2004
  • K010617Spife Ife Calibrator and Control KitHelena Laboratories · 2001
  • K993928Wako-Igg II-HA, Immunoglobulin Calibrator Set, Immunolobulin StandardWako Chemicals USA, Inc. · 2000
  • K993281K-Assay IggKamiya Biomedical Co. · 1999

https://510kreport.com/device/K943997 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943997: Behring Nephelometer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943997

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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