510(k) Report

510(k) · Cleared

Cleared

CX Lipase Reagent & Calibrator for Synchron CX Systems

K952180510(k) TraditionalCleared Aug 17, 1995100-day reviewClass I21 CFR 862.1465

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

Beckman Instruments, Inc. · CHI Lipase-Esterase, Enzymatic, Photometric, Lipase

Cleared on Aug 17, 1995 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 17, 1995
Review
100 days
Class
Class I
Product code
CHI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952180 CX Lipase Reagent & Calibrator for Synchron CX SystemsBeckman Instruments, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK970905 Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc. · 1997 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K970905Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952180CX Lipase Reagent & Calibrator for Synchron CX SystemsBeckman Instruments, Inc.1995—
+1K970905Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc.19971

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K952180, 1995–1997Source: 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 CHI? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K970905Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc.19970

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, K970905 (Beckman Instruments, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CHI devices

CHI Lipase-Esterase, Enzymatic, Photometric, Lipase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHI

FDA has decided no CHI device since 2007.

Median 510(k) review, days · CHI

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

Recalls per year · CHI

1in 2023

2007: 12008: 42010: 12013: 12014: 12018: 32023: 1
2007high 4 (2008) · low 0 (2009)2026

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

Adverse event reports per year · CHI

11in 2025

2008: 12010: 22011: 42012: 12014: 12015: 52016: 32017: 42018: 62019: 22020: 322021: 22022: 42023: 42024: 62025: 11
2007high 32 (2020) · low 0 (2007)2025

MAUDE reports naming product code CHI, 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—10
20080—41
20090—00
20100—12
20110—04
20120—01
20130—10
20140—11
20150—05
20160—03
20170—04
20180—36
20190—02
20200—032
20210—02
20220—04
20230—14
20240—06
20250—011
20260—0—

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in CHI

The CHI category page

  • K970905Synchron CX Systems Lipase (Lipa) ReagentBeckman Instruments, Inc. · 19971 recall
  • K961179Sentinel Lipase Liquid Model 17.401BEqual Diagnostics, Inc. · 1996
  • K952647IL Test LipaseInstrumentation Laboratory CO · 1995
  • K952816Lipase Flex Reagent CartridgeDupont Medical Products · 19953 recalls
  • K941085Lipase-PS Assay Procedure NO. 805Sigma Diagnostics, Inc. · 1994

https://510kreport.com/device/K952180 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952180: CX Lipase Reagent & Calibrator for Synchron CX Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952180

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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