510(k) · Cleared

Cleared

General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer Standoff

K992152510(k) TraditionalCleared Aug 17, 199953-day reviewClass II21 CFR 892.1570

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

CIVCO Medical Instruments Co., Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Aug 17, 1999 as substantially equivalent to K851895 (Parker Laboratories, Inc., 1985) and 6 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Aug 17, 1999
Review: 53 days
Class: Class II
Product code: ITX
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K851895 (1985). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK851895 Polygel Ultrasound GelParker Laboratories, Inc. · 1985
This deviceK992152 General Purpose Transducer Standoff, Biopsy Transducer Standoff…CIVCO Medical Instruments Co., Inc. · 1999
Descendant · cites it directly · 0 of its ownK080119 ClearscanEsi, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K080119ClearscanEsi, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851895	Polygel Ultrasound Gel	Parker Laboratories, Inc.	1985	—
0 (this device)	K992152	General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane…	CIVCO Medical Instruments Co., Inc.	1999	—
+1	K080119	Clearscan	Esi, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1991	1	0
1992	1	0
1994	1	0
1995	1	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K992152, 1985–2008Source: 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 ITX? 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 ITX device

#1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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? (7)

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
*	K851895	Polygel Ultrasound Gel Summary page 4 …ce is identified as substantially equivalent to the following legally marketed device(s): Predicate Device(s) 510(k) Reference Manufacturer Aquaflex® Ultrasound Gel Pad K851895 Parker Laboratories Proxon Sector-Scan Standoff* K873159 Cone Instruments *included in Cone Instruments Combison 310A ultrasound…	Parker Laboratories, Inc.	1985	—
*	K873159	Combison (R) 310A Real Time Ultrasound Scanner Summary page 4 …wing legally marketed device(s): Predicate Device(s) 510(k) Reference Manufacturer Aquaflex® Ultrasound Gel Pad K851895 Parker Laboratories Proxon Sector-Scan Standoff* K873159 Cone Instruments *included in Cone Instruments Combison 310A ultrasound scanner 510(k). Standoff Kit EA 4015 addition to 510(k)…	Cone Instruments, Inc.	1988	—
*	K936024	Ultrasound Scanner 2001 Summary page 4 …included in Cone Instruments Combison 310A ultrasound scanner 510(k). Standoff Kit EA 4015 addition to 510(k) file™* B&K Ultrasound Systems ** July 1997 for 510(k)s K936024, K943315, K905198, K914945, K933056. E. Substantial Equivalence Summary The Ultrasound Transducer Standoff is substantially equ…	B & K Medical A/S	1995	—
*	K943315	Ultrasound Scanner 2002 Summary page 4 …ed in Cone Instruments Combison 310A ultrasound scanner 510(k). Standoff Kit EA 4015 addition to 510(k) file™ B&K Ultrasound Systems ** July 1997 for 510(k)s K936024, K943315, K905198, K914945, K933056. E. Substantial Equivalence Summary The Ultrasound Transducer Standoff is substantially equivalent i…	B&K Medical	1996	—
*	K905198	Diagnostic Ultrasound System Type 3535 Summary page 4 …e Instruments Combison 310A ultrasound scanner 510(k). Standoff Kit EA 4015 addition to 510(k) file™ B&K Ultrasound Systems ** July 1997 for 510(k)s K936024, K943315, K905198, K914945, K933056. E. Substantial Equivalence Summary The Ultrasound Transducer Standoff is substantially equivalent in safety…	Bruel & Kjaer	1991	—
*	K914945	Diagnostic Ultrasound System Type 3535, Modified Summary page 4 …ents Combison 310A ultrasound scanner 510(k). Standoff Kit EA 4015 addition to 510(k) file™ B&K Ultrasound Systems ** July 1997 for 510(k)s K936024, K943315, K905198, K914945, K933056. E. Substantial Equivalence Summary The Ultrasound Transducer Standoff is substantially equivalent in safety and effec…	Bruel & Kjaer Industri A/S	1992	—
*	K933056	Diagnostic Ultrasound System Type 3535, Modified Summary page 4 …ison 310A ultrasound scanner 510(k). Standoff Kit EA 4015 addition to 510(k) file™ B&K Ultrasound Systems ** July 1997 for 510(k)s K936024, K943315, K905198, K914945, K933056. E. Substantial Equivalence Summary The Ultrasound Transducer Standoff is substantially equivalent in safety and effectiveness…	B&K Medical	1994	—

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
K080119	Clearscan	Esi, Inc.	2008	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?

None of the 7 ancestors has a recall.
Of its descendants, K080119 (Esi, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All ITX devices

ITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ITX

4in 2025

2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2007high 15 (2018) · low 0 (2007)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · ITX

571in 2025

2007high 988 (2024) · low 16 (2007)2025

MAUDE reports naming product code ITX, 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	10	26	0	16
2008	12	73	4	39
2009	17	28	4	23
2010	10	42	4	30
2011	10	16	1	34
2012	7	25	1	29
2013	3	105	0	38
2014	4	41	1	43
2015	1	—	5	183
2016	4	151	0	269
2017	6	110	1	412
2018	2	—	15	130
2019	1	—	0	119
2020	3	120	3	116
2021	3	139	10 (10)	146
2022	2	—	6	87
2023	6	213	1	138
2024	3	81	1	988
2025	4	126	2	571
2026	6	158	0	—

What is it indicated for?

The Ultrasound Transducer Standoff is placed over a diagnostic ultrasound transducer / probe / scanhead to control the distance (offset) between transducer and body surfaces for optimal focusing by shifting the transducer, effectively offsetting the focal zone, for improved visualization of near-field and superficial structures. The transducer standoff device can be used to perform scanning and needle guided procedures for body surface and endocavity diagnostic ultrasound. Standoff devices are furnished as a non-sterile; single use patient / procedure, with limited reuse capability (as designated in instructions for use) if properly cleaned / disinfected between patient uses.

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/K992152 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992152: General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer Standoff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992152

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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