510(k) · Cleared

Cleared

Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900

K000960510(k) TraditionalCleared May 26, 200063-day reviewClass II21 CFR 892.1560

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

Barzell-Whitmore Maroon Bells, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 26, 2000 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: May 26, 2000
Review: 63 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

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

This deviceK000960 Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900Barzell-Whitmore Maroon Bells, Inc. · 2000
Descendant · cites it directly · 0 of its ownK030518 Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003
Descendant · cites it directly · 0 of its ownK024183 Alton PT StepperAlton Design, LLC · 2003

Most influential descendants

Showing 2 of 2 · See all

K030518Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003 · cites it directly0descendants
K024183Alton PT StepperAlton Design, LLC · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000960	Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900	Barzell-Whitmore Maroon Bells, Inc.	2000	—
+1	K030518	Ameritek Sure-Point Tracker System	Amertek Medical, Inc.	2003	—
+1	K024183	Alton PT Stepper	Alton Design, LLC	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0

FIG. 1 — Lineage of K000960, 2000–2003Source: 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.

Planning a device in IYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030518	Ameritek Sure-Point Tracker System	Amertek Medical, Inc.	2003	0
K024183	Alton PT Stepper	Alton Design, LLC	2003	0

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, K030518 (Amertek Medical, Inc., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

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

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K000960 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000960: Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000960

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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