510(k) · Cleared

Cleared

Terason Model 2000/Bas Portable Ultrasound System

K030191510(k) TraditionalCleared Jan 29, 20038-day reviewClass II21 CFR 892.1550

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

Teratech Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jan 29, 2003 as substantially equivalent to K012191 (Teratech Corp., 2001) and 2 other predicates after an 8-day review. Its family tree reaches back 3 generations to 1993. 24 later devices descend from it.

Decided: Jan 29, 2003
Review: 8 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K926514 (1993). 10 ancestors in all, the oldest K850478 (1985). 24 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
2 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
1 generation backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
This deviceK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
Descendant · cites it directly · 13 of its ownK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
Descendant · 2 generations on · 12 of its ownK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
Descendant · 3 generations on · 9 of its ownK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
Descendant · 4 generations on · 8 of its ownK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
Descendant · 5 generations on · 7 of its ownK141110 Cryocare CS Surgical SystemHealthtronics · 2015

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2003high 3 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 24 · See all

K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003 · cites it directly13descendants
K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005 · 2 generations on12descendants
K060279Cryocare CS Surgical SystemEndocare, Inc. · 2006 · 3 generations on9descendants
K101333Cryocare CS Surgical SystemEndocare, Inc. · 2010 · 4 generations on8descendants
K141110Cryocare CS Surgical SystemHealthtronics · 2015 · 5 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K926514	Endoscopic Ultrasound System Type 20	Olympus Corp.	1993	1
−2	K963023	Ultrasound Gastroscope GF Type UM30P	Olympus America, Inc.	1997	—
−1	K994373	Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound…	Atl Ultrasound, Inc.	2000	—
0 (this device)	K030191	Terason Model 2000/Bas Portable Ultrasound System	Teratech Corp.	2003	—
+1	K032333	Cryocare CS Surgical System	Endocare, Inc.	2003	—
+2	K050347	Modification to Cryocare CS Surgical System	Endocare, Inc.	2005	—
+3	K060279	Cryocare CS Surgical System	Endocare, Inc.	2006	3
+4	K101333	Cryocare CS Surgical System	Endocare, Inc.	2010	2
+5	K141110	Cryocare CS Surgical System	Healthtronics	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1986	1	0
1994	1	0
1997	1	0
1999	2	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	2	0
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2015	2	0
2016	2	0
2018	1	0
2020	2	0
2021	1	0
2022	1	0
2023	3	0
2024	1	0
2025	3	0

FIG. 1 — Lineage of K030191, 1993–2025Source: 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 IYN? 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 IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K012191	Teratech Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes Summary page 7 …ty monitoring of follicle development. Additional Comments: P': uses previously cleared under K992505 with 3 MHz Model L3 (Linear); P2: uses previously cleared under K012191, P3: uses previously cleared under KO10883 Includes uses in military field settings in addition to hospital/clinic settinqs.…	Teratech Corp.	2001	—
*	K994373	Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer… Summary page 1 …d Ultrasound System KO 12191 Date Cleared: July 26,2001 (2): ATL HDITM1500 Diagnostic Ultrasound System and Transducers IS994373 Date Cleared: May 24,2000 (3) Dymax Corp. Site-Rite 3 Ultrasound Scanner K993624…	Atl Ultrasound, Inc.	2000	—
*	K993624	Site-Rite 3 Ultrasound System Summary page 1 …ostic Ultrasound System and Transducers IS994373 Date Cleared: May 24,2000 (3) Dymax Corp. Site-Rite 3 Ultrasound Scanner K993624 Date Cleared: November 10,1999 TERATECH Corp. 5 1O(k) 12116/02 CONFIDENTIAL…	Dymax Corp	1999	—
†	K992505	Teratech, Model 2000 Imaging Imaging	Teratech Corp.	1999	—
†	K010883	Teratech Model 8EC4 Endocavity Smart Probe	Teratech Corp.	2001	—

Also cleared against K012191: 1 other device →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K032333	Cryocare CS Surgical System	Endocare, Inc.	2003	13
K061153	Gynesonics EC6 Transducer	Gynesonics, Inc.	2006	7
K072266	Acuson P50 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2007	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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
2 of the 10 ancestors have a recall of any class.
Of its descendants, K032333 (Endocare, Inc., 2003) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K012191.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

The TERASON Model 2000/BAS Portable Ultrasound Systems are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030191 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030191: Terason Model 2000/Bas Portable Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030191

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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