510(k) · Cleared

Recalled · 2003

Reporting Integrator 3392A

K833113510(k) TraditionalCleared Nov 21, 198369-day reviewClass I21 CFR 862.2260Recalls 2

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

Hewlett-Packard Co. · LDM Instrumentation, High Pressure Liquid Chromatography

Cleared on Nov 21, 1983 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided: Nov 21, 1983
Review: 69 days
Class: Class I
Product code: LDM
Recalls: 2
Predicates: 0

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

This deviceK833113 Reporting Integrator 3392AHewlett-Packard Co. · 1983
Descendant · cites it directly · 0 of its ownK960392 CDMBio-Rad · 1996

Most influential descendants

Showing 1 of 1 · See all

K960392CDMBio-Rad · 1996 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K833113	Reporting Integrator 3392A	Hewlett-Packard Co.	1983	—
+1	K960392	CDM	Bio-Rad	1996	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K833113, 1983–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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.

Number	Device	Applicant	Decided	Descendants
K960392	CDM	Bio-Rad	1996	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 17, 2003	Not classified	Z-0324-04	Other	Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
Dec 11, 2002	Not classified	Z-0690-03	Other	Unexpected false positive TCA results

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K960392 (Bio-Rad, 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LDM devices

LDM Instrumentation, High Pressure Liquid Chromatography: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDM

FDA has decided no LDM device since 2007.

Median 510(k) review, days · LDM

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

Recalls per year · LDM

No recall names LDM since 2007.

Adverse event reports per year · LDM

1in 2022

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code LDM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	1
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K833113 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833113: Reporting Integrator 3392A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833113

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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