510(k) Report

510(k) · Cleared

Cleared

SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device

K173316510(k) TraditionalCleared Jun 19, 2018243-day reviewClass II21 CFR 876.1075

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

Transmed7, LLC · KNW Instrument, Biopsy

Cleared on Jun 19, 2018 as substantially equivalent to K053151 (Rubicor Medical, Inc., 2005) and 3 other predicates after a 243-day review. Its family tree reaches back 6 generations to 2001.

Decided
Jun 19, 2018
Review
243 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K003528 (2001). 19 ancestors in all, the oldest K970565 (1997). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2016: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2012: 1 other ancestor2001: 2 other ancestors1999: 1 other ancestor1997: 1 other ancestor2009: 1 other ancestor2004: 2 other ancestors2008: 1 other ancestor2006: 1 other ancestorK003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 2001×2: 2 generations cleared close together, K021137 (2002), K022879 (2002) K032506 · Sanarus Centrica II Rotational Core Biopsy System · Sanarus Medical, Inc. · 2003K042136 · Sanarus Cassi Rotational Core Biopsy System · Sanarus Medical, Inc. · 2004K051581 · Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 · Sanarus Medical, Inc. · 2005199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 2 other ancestors4 generations back: 2 other ancestors5 generations back: 1 other ancestor K051581 · Sanarus Cassi II Rotational Core Biopsy System, Model CS2000 · Sanarus Medical, Inc. · 2005K042136 · Sanarus Cassi Rotational Core Biopsy System · Sanarus Medical, Inc. · 2004K032506 · Sanarus Centrica II Rotational Core Biopsy System · Sanarus Medical, Inc. · 2003K022879 · Modification to Sanarus Centrica Core Tissue Biopsy · Sanarus Medical, Inc. · 2002 · recalledK021137 · Sanarus Centrica Core Tissue Biopsy System · Sanarus Medical, Inc. · 2002K003528 · Sanarus Core Tissue Biopsy System · Endocare, Inc. · 2001−50
  1. Root · 6 generations backK003528 Sanarus Core Tissue Biopsy SystemEndocare, Inc. · 2001
  2. 5 generations backK021137 Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc. · 2002
  3. 4 generations backK022879 Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc. · 2002 · Recalled
  4. 3 generations backK032506 Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc. · 2003
  5. 2 generations backK042136 Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc. · 2004
  6. 1 generation backK051581 Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc. · 2005
  7. This deviceK173316 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU…Transmed7, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K003528Sanarus Core Tissue Biopsy SystemEndocare, Inc.2001—
−5K021137Sanarus Centrica Core Tissue Biopsy SystemSanarus Medical, Inc.2002—
−4K022879Modification to Sanarus Centrica Core Tissue BiopsySanarus Medical, Inc.20021
−3K032506Sanarus Centrica II Rotational Core Biopsy SystemSanarus Medical, Inc.2003—
−2K042136Sanarus Cassi Rotational Core Biopsy SystemSanarus Medical, Inc.2004—
−1K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000Sanarus Medical, Inc.2005—
0 (this device)K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft…Transmed7, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200120
200310
200420
200510
200610
200810
200910
201210
201610
FIG. 1 — Lineage of K173316, 2001–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 KNW? 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 KNW device

  1. #1 K260572 Marrow Marxmanscore 14.5 · 10 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? (4)

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
*K053151Rubicor Magic Breast Biopsy Device
Summary page 4
…75, Product Code KNW Classification Class II Magic™ Breast Biopsy Device K053151 Sanarus Cassi™ II Rotational Core Biopsy System K051581…
Rubicor Medical, Inc.2005—
*K051581Sanarus Cassi II Rotational Core Biopsy System, Model CS2000
Summary page 4
…Magic™ Breast Biopsy Device K053151 Sanarus Cassi™ II Rotational Core Biopsy System K051581 BIP VacuFlash® Biopsy System K024089 Predicate Devices…
Sanarus Medical, Inc.2005—
*K024089Vacuflash Biopsy System
Summary page 4
…Sanarus Cassi™ II Rotational Core Biopsy System K051581 BIP VacuFlash® Biopsy System K024089 Predicate Devices BIP USA Inc. / C.R. Bard Medical, Inc.…
Bip USA, Inc.2003—
*K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…
Summary page 4
…BIP USA Inc. / C.R. Bard Medical, Inc. Mammotome elite® Biopsy System / Devicor Medical, K153709 Inc. Device Descriptions SpeedBird Model SB38 Soft Tissue Biopsy Device Descriptio…
Devicor Medical Products, Inc.2016—

Also cleared against K053151: 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)

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 17 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 5 of the 19 ancestors have a recall of any class.
  • 1 other device also cites its predicate K053151.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · KNW

12in 2025

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

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

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
2007high 5,120 (2020) · low 67 (2011)2025

MAUDE reports naming product code KNW, 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
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—

What is it indicated for?

The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses. The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including breast…

Read the full statement (173 words)

The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses.

The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissue for histologic examination, with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Indications for use as stated in the FDA summary.

Also cleared against K053151

1 other device cites the same predicate.

  • K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc. · 2007

More from Transmed7, LLC

2 FDA decisions under this applicant name. See the company

  • K201244Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy DevicesTransmed7, LLC · 2020

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K173316 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173316: SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173316

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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