510(k) Report

510(k) · Cleared

Cleared

Behring Nephelometer 100

K892223510(k) TraditionalCleared May 4, 198931-day reviewClass I21 CFR 866.4540

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

Behring Diagnostics, Inc. · JZW Nephelometer

Cleared on May 4, 1989 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 4, 1989
Review
31 days
Class
Class I
Product code
JZW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K892223Source: 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 JZW? 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?

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 JZW devices

JZW Nephelometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JZW

FDA has decided no JZW device since 2007.

Median 510(k) review, days · JZW

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

Recalls per year · JZW

No recall names JZW since 2007.

Adverse event reports per year · JZW

2in 2025

2016: 32017: 22018: 82020: 62021: 62022: 52023: 12024: 22025: 2
2007high 8 (2018) · low 0 (2007)2025

MAUDE reports naming product code JZW, 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—03
20170—02
20180—08
20190—00
20200—06
20210—06
20220—05
20230—01
20240—02
20250—02
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 JZW

The JZW category page

  • K001647BN Prospec SystemDade Behring, Inc. · 20001 recall
  • K761234Behring Laser NephelometerBehring Diagnostics, Inc. · 1990
  • K873401TurboxUnipath, Ltd. · 1987
  • K873407RRT System Laser Reflectometer AnalyzerIncstar Corp. · 1987
  • K801949BCM-302 Collimating Cone & CompensatinB C Medical, Ltd. · 1980

https://510kreport.com/device/K892223 · printed Nov 4, 2026

Cite this page

510(k) Report. “K892223: Behring Nephelometer 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892223

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