510(k) Report

510(k) · Cleared

Cleared

Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan)

K952350510(k) TraditionalCleared Jul 17, 199559-day reviewClass II

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

Promedical, Ltd. · LWE Bone Marrow Collection/Transfusion Kit

Cleared on Jul 17, 1995 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jul 17, 1995
Review
59 days
Class
Class II
Product code
LWE
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2007: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952350 Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy…Promedical, Ltd. · 1995
  2. Descendant · cites it directly · 1 of its ownK013692 Trapsystem SetH.S. Hospital Service S.R.L. · 2002
  3. Descendant · 2 generations on · 0 of its ownK070179 Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie · 2007

Most influential descendants

Showing 2 of 2 · See all
  • K013692Trapsystem SetH.S. Hospital Service S.R.L. · 2002 · cites it directly1descendant
  • K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie · 2007 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952350Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle…Promedical, Ltd.1995—
+1K013692Trapsystem SetH.S. Hospital Service S.R.L.2002—
+2K070179Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
FIG. 1 — Lineage of K952350, 1995–2007Source: 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 LWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013692Trapsystem SetH.S. Hospital Service S.R.L.20021

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, K013692 (H.S. Hospital Service S.R.L., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LWE devices

LWE Bone Marrow Collection/Transfusion Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWE

FDA has decided no LWE device since 2007.

Median 510(k) review, days · LWE

Too few LWE 510(k)s in any year since 2007 to give a median.

Recalls per year · LWE

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LWE

1in 2025

2010: 22011: 12013: 12015: 12017: 22018: 12019: 52020: 32021: 82022: 62023: 12025: 1
2007high 8 (2021) · low 0 (2007)2025

MAUDE reports naming product code LWE, 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
20070—00
20080—00
20090—00
20100—12
20110—01
20120—00
20130—01
20140—00
20150—01
20160—00
20170—02
20180—01
20190—05
20200—03
20210—08
20220—06
20230—01
20240—00
20250—01
20260—0—

More from Promedical, Ltd.

5 FDA decisions under this applicant name. See the company

  • K954596Pro-B Core-Rect Coaxial Biopsy SystemPromedical, Ltd. · 1995
  • K951598Pro-B Biopsy NeedlePromedical, Ltd. · 1995
  • K944944Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy NeedlePromedical, Ltd. · 1994
  • K944942Breast Lesion Localization NeedlePromedical, Ltd. · 1994

Recent decisions in LWE

The LWE category page

  • K913306Bone-Temno/Sternum-TemnoProact, Ltd. · 19915 recalls
  • K871198Bone Marrow Collection Kit and StandBaxter Healthcare Corp · 1987

https://510kreport.com/device/K952350 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952350: Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952350

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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