510(k) · Cleared
ClearedPajunk's Primocut Disposable Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · MJG Device, Percutaneous, Biopsy
Cleared on May 9, 2008 as substantially equivalent to K052802 (Manan Medical Products, Inc., 2005) and 1 other predicate after a 60-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 9, 2008
- Review
- 60 days
- Class
- Class I
- Product code
- MJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K950732 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
- 2 generations backK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
- 1 generation backK052802 Manan Bio-Cut Soft Tissue Biopsy NeedleManan Medical Products, Inc. · 2005
- This deviceK080674 Pajunk's Primocut Disposable Biopsy SystemPAJUNK GmbH Medizintechnologie · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950732 | Manan Super-Core Biopsy Needle | Manan Medical Products, Inc. | 1995 | — |
| −2 | K974814 | Manan (TM) Super-Core Biopsy Needles | Medical Device Technologies, Inc. | 1998 | 1 |
| −1 | K052802 | Manan Bio-Cut Soft Tissue Biopsy Needle | Manan Medical Products, Inc. | 2005 | — |
| 0 (this device) | K080674 | Pajunk's Primocut Disposable Biopsy System | PAJUNK GmbH Medizintechnologie | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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 MJG? 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
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleSummary page 1…9611612 Regulatory Class: II Product Code: KNW Panel: Gastroenterology/Urology Predicate Devices: 1. K052802 Manan BioCut soft tissue Biopsy needle 2. K024120 TEMVNO® semi automated biopsy device,… | 2005 |
| * | K024120 | Modification to Temno Biopsy NeedlesSummary page 1…anel: Gastroenterology/Urology Predicate Devices: 1. K052802 Manan BioCut soft tissue Biopsy needle 2. K024120 TEMVNO® semi automated biopsy device, Allegiance Indications for use: PAJUNKO'… | 2003 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All MJG devicesMJG Device, Percutaneous, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MJG
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MJG
Too few MJG 510(k)s in any year since 2007 to give a median.
Recalls per year · MJG
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJG
1in 2025
MAUDE reports naming product code MJG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PAJUNKI's PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080674 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080674: Pajunk's Primocut Disposable Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080674
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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