510(k) Report

510(k) · Cleared

Cleared

Bone Biopsy Needle

K001132510(k) TraditionalCleared May 1, 200021-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

Promex, Inc. · KNW Instrument, Biopsy

Cleared on May 1, 2000 after a 21-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 22 later devices descend from it.

Decided
May 1, 2000
Review
21 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

22 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2015: 3 descendants cleared2014: 3 descendants cleared2019: 3 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2021: 3 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK001132 Bone Biopsy NeedlePromex, Inc. · 2000
  2. Descendant · cites it directly · 19 of its ownK050795 Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005
  3. Descendant · 2 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
  4. Descendant · 3 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
  5. Descendant · 3 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
  6. Descendant · 3 generations on · 1 of its ownK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005: 22008: 12013: 12014: 32015: 32018: 12019: 32020: 12021: 32023: 12024: 12025: 12026: 1
2005high 3 (2014) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all
  • K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005 · cites it directly19descendants
  • K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 2 generations on12descendants
  • K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 3 generations on5descendants
  • K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 3 generations on4descendants
  • K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001132Bone Biopsy NeedlePromex, Inc.2000—
+1K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.2005—
+2K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.2013—
+3K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.2014—
+3K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.2015—
+3K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200810
201310
201430
201530
201810
201930
202010
202130
202310
202410
202510
202610
FIG. 1 — Lineage of K001132, 2000–2026Source: 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), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.200519
K080095Coramate/Spirotome SystemMedinvents20081

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?

  • Of its descendants, K050795 (Orthovita, Inc., 2005) has gone furthest, with 19 descendants of its own.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)—

More from Promex, Inc.

18 FDA decisions under this applicant name. See the company

  • K023450Biopsy Site Tissue Marker DevicePromex, Inc. · 2002
  • K022634CO-Axial Introducer NeedlePromex, Inc. · 20026 recalls
  • K010400Vacuum Assisted Core Biopsy DevicePromex, Inc. · 20015 recalls
  • K011270Automated Core Biopsy DevicePromex, Inc. · 2001
  • K994272Automated Core Biopsy DevicePromex, Inc. · 2000

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/K001132 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001132: Bone Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001132

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026