510(k) Report

510(k) · Cleared

Cleared

Medax Biopsy Systems III

K181803510(k) TraditionalCleared Oct 18, 2018105-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

Medax Srl Unipersonale · KNW Instrument, Biopsy

Cleared on Oct 18, 2018 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.

Decided
Oct 18, 2018
Review
105 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2020: 2 descendants cleared2026: 1 descendant cleared201620182020202220242026
  1. This deviceK181803 Medax Biopsy Systems IIIMedax Srl Unipersonale · 2018
  2. Descendant · cites it directly · 2 of its ownK192101 Medone Ultra, MedextraMedax Srl Unipersonale · 2020
  3. Descendant · cites it directly · 1 of its ownK210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy…Promisemed Hangzhou Meditech Co., Ltd. · 2021
  4. Descendant · 2 generations on · 0 of its ownK261196 Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026
  5. Descendant · cites it directly · 0 of its ownK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020

Most influential descendants

Showing 4 of 4 · See all
  • K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020 · cites it directly2descendants
  • K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd. · 2021 · cites it directly1descendant
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026 · 2 generations on0descendants
  • K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K181803Medax Biopsy Systems IIIMedax Srl Unipersonale2018—
+1K192101Medone Ultra, MedextraMedax Srl Unipersonale2020—
+1K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices…Promisemed Hangzhou Meditech Co., Ltd.2021—
+2K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.2026—
+1K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle…Medax Srl Unipersonale2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202110
202610
FIG. 1 — Lineage of K181803, 2018–2026Source: 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), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K192101Medone Ultra, MedextraMedax Srl Unipersonale20202
K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd.20211
K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200

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, K192101 (Medax Srl Unipersonale, 2020) has gone furthest, with 2 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. 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?

MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy PERFECTUS, HANDLEX biopsy needle must be used…

Read the full statement (147 words)

MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy

NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy

PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or iliac crest

HEPAX biopsy needle is intended for use in obtaining histological and cytological biopsies of soft tissues. It is not intended for use in bone biopsy.

FNA (Chiba/Quincke/Turner/Westcott/Franseen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

Indications for use as stated in the FDA 510(k) statement.

More from Medax Srl Unipersonale

5 FDA decisions under this applicant name. See the company

  • K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020
  • K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and…Medax Srl Unipersonale · 2020
  • K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale · 2017
  • K142125New Medax Biopsy SystemsMedax Srl Unipersonale · 2015

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/K181803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181803: Medax Biopsy Systems III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181803

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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