510(k) · Cleared

Cleared

Mini Sampler Processor

K970616510(k) TraditionalCleared Apr 21, 199762-day reviewClass I21 CFR 862.2750

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

Cavro Scientific Instruments, Inc. · JQW Station, Pipetting And Diluting, For Clinical Use

Cleared on Apr 21, 1997 after a 62-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Apr 21, 1997
Review: 62 days
Class: Class I
Product code: JQW
Recalls: None
Predicates: 0

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

This deviceK970616 Mini Sampler ProcessorCavro Scientific Instruments, Inc. · 1997
Descendant · cites it directly · 1 of its ownK023955 BD Viper InstrumentBecton, Dickinson & CO · 2003
Descendant · 2 generations on · 0 of its ownK052481 BD Viper SystemBecton, Dickinson & CO · 2005

Most influential descendants

Showing 2 of 2 · See all

K023955BD Viper InstrumentBecton, Dickinson & CO · 2003 · cites it directly1descendant
K052481BD Viper SystemBecton, Dickinson & CO · 2005 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970616	Mini Sampler Processor	Cavro Scientific Instruments, Inc.	1997	—
+1	K023955	BD Viper Instrument	Becton, Dickinson & CO	2003	—
+2	K052481	BD Viper System	Becton, Dickinson & CO	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0

FIG. 1 — Lineage of K970616, 1997–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JQW? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Mini Sample Processor MSP 9000 Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K023955	BD Viper Instrument	Becton, Dickinson & CO	2003	1

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, K023955 (Becton, Dickinson & CO, 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JQW devices

JQW Station, Pipetting And Diluting, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQW

FDA has decided no JQW device since 2007.

Median 510(k) review, days · JQW

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

Recalls per year · JQW

1in 2017

2007high 3 (2010) · low 0 (2013)2026

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

Adverse event reports per year · JQW

11in 2025

2007high 44 (2022) · low 2 (2017)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	41
2008	—	2	20
2009	—	2	5
2010	—	3	4
2011	—	2	32
2012	—	2	17
2013	—	0	11
2014	—	1	11
2015	—	0	6
2016	—	2	5
2017	—	1	2
2018	—	0	4
2019	—	0	2
2020	—	0	27
2021	—	0	30
2022	—	0	44
2023	—	0	36
2024	—	0	15
2025	—	0	11
2026	—	0	—

What is it indicated for?

It is intended to be used for automating sample preparation or assay methods and is capable of aspirating, dispensing or diluting fluids to any position on the instruments work area.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970616 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970616: Mini Sampler Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970616

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026