510(k) Report

510(k) · Cleared

Cleared

Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory

K972672510(k) TraditionalCleared Jul 29, 199713-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

Barzell-Whitmore Maroon Bells, Inc. · ITX Transducer, Ultrasonic, Diagnostic

Cleared on Jul 29, 1997 as substantially equivalent to K905198 (Bruel & Kjaer, 1991) and 3 other predicates after a 13-day review. Its family tree reaches back 1 generation to 1985. 6 later devices descend from it.

Decided
Jul 29, 1997
Review
13 days
Class
Class II
Product code
ITX
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K850571 (1985). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1999: 1 descendant cleared2003: 2 descendants cleared2013: 2 descendants cleared2017: 1 descendant clearedK850571 · I-125 Implant Gun · Mick Radio-Nuclear Instruments, Inc. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants K850571 · I-125 Implant Gun · Mick Radio-Nuclear Instruments, Inc. · 19850
  1. Root · 1 generation backK850571 I-125 Implant GunMick Radio-Nuclear Instruments, Inc. · 1985
  2. This deviceK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
  3. Descendant · cites it directly · 1 of its ownK131161 EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper…CIVCO Medical Instruments Co., Inc. · 2013
  4. Descendant · cites it directly · 1 of its ownK982696 InterplantBurdette Medical Systems, Inc. · 1999 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and…Koelis · 2017
  6. Descendant · 2 generations on · 0 of its ownK131428 RadvisionAcoustic Medsystems, Inc. · 2013
  7. Descendant · cites it directly · 0 of its ownK023430 UF Brachytherapy StandUniversity of Florida · 2003

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999: 12003: 22013: 22017: 1
1999high 2 (2003) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all
  • K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc. · 2013 · cites it directly1descendant
  • K982696InterplantBurdette Medical Systems, Inc. · 1999 · cites it directly1descendant
  • K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis · 2017 · 2 generations on0descendants
  • K131428RadvisionAcoustic Medsystems, Inc. · 2013 · 2 generations on0descendants
  • K023430UF Brachytherapy StandUniversity of Florida · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850571I-125 Implant GunMick Radio-Nuclear Instruments, Inc.1985—
0 (this device)K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand…Barzell-Whitmore Maroon Bells, Inc.1997—
+1K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc.2013—
+1K982696InterplantBurdette Medical Systems, Inc.19991
+2K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD…Koelis2017—
+2K131428RadvisionAcoustic Medsystems, Inc.2013—
+1K023430UF Brachytherapy StandUniversity of Florida2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200320
201320
201710
FIG. 1 — Lineage of K972672, 1985–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K905198Diagnostic Ultrasound System Type 3535
Summary page 2
…facturer: 510(k) Number: Substantial Equivalence Date: Device Name: Manufacturer: 510(k) Number: Substantial Equivalence Date: B & K Stepper Brel & Kjaer Medical K905198 & K914945 8/28/91 & 6/26/92 Civco Ultra-Step Civco Instruments Unknown Unknown 2. Predicate Devices for the BRACHYSTEPPER Needl…
Bruel & Kjaer1991—
*K914945Diagnostic Ultrasound System Type 3535, Modified
Summary page 2
…510(k) Number: Substantial Equivalence Date: Device Name: Manufacturer: 510(k) Number: Substantial Equivalence Date: B & K Stepper Brel & Kjaer Medical K905198 & K914945 8/28/91 & 6/26/92 Civco Ultra-Step Civco Instruments Unknown Unknown 2. Predicate Devices for the BRACHYSTEPPER Needle Guide Te…
Bruel & Kjaer Industri A/S1992—
*K875241Civco Seed Implant Needle Guide
Summary page 2
…er: Substantial Equivalence Date: Device Name: Manufacturer: 510(k) Number: Substantial Equivalence Date: Civco Seed Implant Needle Guide Civco Medical Instruments K875241 4/14/88 B & K Stepper Matrix Brel & Kjaer Medical K905198 & K914945 8/28/91 & 6/26/92 3. Predicate Device for the BRACHYSTAND…
CIVCO Medical Instruments Co., Inc.1988—
*K850571I-125 Implant Gun
Summary page 2
…rer: 510(k) Number: Substantial Equivalence Date: XABwm\510(k)\L. 061697 Brady Submission (MHC).doc “Martin” Immobilizing Device Mick Radio-Nuclear Instruments, Inc. K850571 3/26/85 Ultra-Step Ultrasound Probe/Stepper Fixation Device Civco Medical Instruments Co., Inc. Unknown Unknown === Page 3 =…
Mick Radio-Nuclear Instruments, Inc.1985—
*—Civco Ultra-Step
Named without a submission number
—
*—Ultra-Step Ultrasound Probe/Stepper Fixation Device
Named without a submission number
—

Also cleared against K905198: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc.20131
K982696InterplantBurdette Medical Systems, Inc.19991
K023430UF Brachytherapy StandUniversity of Florida20030
K024183Alton PT StepperAlton Design, LLC20030

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 4 ancestors has a recall.
  • Of its descendants, K131161 (CIVCO Medical Instruments Co., Inc., 2013) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K905198.

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

2007: 102008: 122009: 172010: 102011: 102012: 72013: 32014: 42015: 12016: 42017: 62018: 22019: 12020: 32021: 32022: 22023: 62024: 32025: 42026 (partial year): 6
2007high 17 (2009) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ITX

126in 2025

2007: 26 days median2008: 73 days median2009: 28 days median2010: 42 days median2011: 16 days median2012: 25 days median2013: 105 days median2014: 41 days median2016: 151 days median2017: 110 days median2020: 120 days median2021: 139 days median2023: 213 days median2024: 81 days median2025: 126 days median2026 (partial year): 158 days median
2007high 213 (2023) · low 16 (2011)2026

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

Recalls per year · ITX

2in 2025

2008: 42009: 42010: 42011: 12012: 12014: 12015: 52017: 12018: 152020: 32021: 10, 10 Class I2022: 62023: 12024: 12025: 2
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

2007: 162008: 392009: 232010: 302011: 342012: 292013: 382014: 432015: 1832016: 2692017: 4122018: 1302019: 1192020: 1162021: 1462022: 872023: 1382024: 9882025: 571
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071026016
20081273439
20091728423
20101042430
20111016134
2012725129
20133105038
2014441143
20151—5183
201641510269
201761101412
20182—15130
20191—0119
202031203116
2021313910 (10)146
20222—687
202362131138
20243811988
202541262571
202661580—

What is it indicated for?

This device is indicated for use in adult males with known or suspected prostate cancer.

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

Also cleared against K905198

3 other devices cite the same predicate.

  • K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer StandoffCIVCO Medical Instruments Co., Inc. · 1999
  • K980997PGK Device (Modified)Pgk, Inc. · 1998
  • K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997

More from Barzell-Whitmore Maroon Bells, Inc.

2 FDA decisions under this applicant name. See the company

  • K000960Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900Barzell-Whitmore Maroon Bells, Inc. · 2000

Recent decisions in ITX

The ITX category page

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc. · 2026
  • K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd. · 2026
  • K262474ND Needle Guidance SystemAccurate Access, LLC · 2026

https://510kreport.com/device/K972672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972672: Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972672

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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