510(k) · Cleared

Recalled · 2004

Ultrasound Scanner, Model Type 2101

K991937510(k) SpecialCleared Jul 30, 199951-day reviewClass II21 CFR 892.1560Recalls 1

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

B & K Medical A/S · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jul 30, 1999 as substantially equivalent to K943315 (B&K Medical, 1996) after a 51-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.

Decided: Jul 30, 1999
Review: 51 days
Class: Class II
Product code: IYO
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K943315 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK943315 Ultrasound Scanner 2002B&K Medical · 1996
This deviceK991937 Ultrasound Scanner, Model Type 2101B & K Medical A/S · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943315	Ultrasound Scanner 2002	B&K Medical	1996	—
0 (this device)	K991937	Ultrasound Scanner, Model Type 2101	B & K Medical A/S	1999	—

FIG. 1 — Lineage of K991937, 1996–1999Source: 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 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? (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
*	K943315	Ultrasound Scanner 2002 Summary page 1 …1 are Track 3 transducers. Intended use. 2101-intended uses are contained within 2002-intended uses: Predicate device, Submitted device, Ultrasound scanner Type 2002 (K943315) \| Ultrasound scanner Type 2101 Modes of operation \| B, M, PWD, CFM and combinations B, M and combinations Intended use(clinical…	B&K Medical	1996	—

Also cleared against K943315: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 12, 2004	Not classified	Z-0271-05	Other	Defect at probe tip may effect sterilization and electrical safety

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate K943315.

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	—

What is it indicated for?

Ultrasound scanner and transducers for B, M and combined mode imaging. Guidance of biopsy needles, geometrical measurements and calculation of parameters.

Non monitoring ECG for superimposing the ultrasound information.

Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal.

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/K991937 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991937: Ultrasound Scanner, Model Type 2101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991937

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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