510(k) Report

510(k) · Cleared

Cleared

Temno Achieve Biopsy Needle

K960064510(k) TraditionalCleared Apr 5, 199691-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

Bauer Medical, Inc. · KNW Instrument, Biopsy

Cleared on Apr 5, 1996 after a 91-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
Apr 5, 1996
Review
91 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

22 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared2009: 1 descendant cleared2021: 2 descendants cleared2017: 2 descendants cleared2023: 1 descendant cleared2020: 3 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2022: 4 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK960064 Temno Achieve Biopsy NeedleBauer Medical, Inc. · 1996
  2. Descendant · cites it directly · 11 of its ownK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
  3. Descendant · cites it directly · 7 of its ownK130616 Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles…Biopsybell S.R.L. · 2014 · Recalled
  4. Descendant · cites it directly · 4 of its ownK160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable…M.D.L. S.R.L. · 2016 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK192101 Medone Ultra, MedextraMedax Srl Unipersonale · 2020
  6. Descendant · 2 generations on · 1 of its ownK222462 Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic…Itp Innovative Tomography Products GmbH · 2023

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2009: 12014: 22015: 12016: 12017: 22020: 32021: 22022: 42023: 12024: 22025: 22026: 1
2009high 4 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 22 · See all
  • K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014 · cites it directly11descendants
  • K130616Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesBiopsybell S.R.L. · 2014 · cites it directly7descendants
  • K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L. · 2016 · cites it directly4descendants
  • K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020 · 2 generations on2descendants
  • K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…Itp Innovative Tomography Products GmbH · 2023 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K960064Temno Achieve Biopsy NeedleBauer Medical, Inc.1996—
+1K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion2014—
+1K130616Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles…Biopsybell S.R.L.20142
+1K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy…M.D.L. S.R.L.20161
+2K192101Medone Ultra, MedextraMedax Srl Unipersonale2020—
+2K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM…Itp Innovative Tomography Products GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201420
201510
201610
201720
202030
202120
202240
202310
202420
202520
202610
FIG. 1 — Lineage of K960064, 1996–2026Source: 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), 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?

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

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

NumberDeviceApplicantDecidedDescendants
K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion201411
K130616Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesBiopsybell S.R.L.20147
K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L.20164
K150169Sertera Biopsy DeviceHologic, Inc.20150
K093256Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018Inrad20090

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, K141552 (Care Fusion, 2014) has gone furthest, with 11 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 Bauer Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K960065Temno Double Shot Biopsy NeedleBauer Medical, Inc. · 1996
  • K935538Bauer Temno Coaxial NeedleBauer Medical, Inc. · 1994

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/K960064 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960064: Temno Achieve Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960064

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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