510(k) · Cleared
ClearedBiopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fehling Instruments GmbH · DWZ Device, Biopsy, Endomyocardial
Cleared on Sep 30, 2025 as substantially equivalent to K170726 (Fehling Instruments GmbH & Co. KG, 2017) after a 33-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Sep 30, 2025
- Review
- 33 days
- Class
- Class II
- Product code
- DWZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K870186 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK870186 Endomyocardial Biopsy DeviceMansfield Scientific, Inc. · 1987
- 2 generations backK973818 T-Rex Biopsy ForcepsBoston Scientific Corp · 1997
- 1 generation backK170726 Biopsy ForcepsFehling Instruments GmbH & Co. KG · 2017
- This deviceK252722 Biopsy ForcepsFehling Instruments GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870186 | Endomyocardial Biopsy Device | Mansfield Scientific, Inc. | 1987 | — |
| −2 | K973818 | T-Rex Biopsy Forceps | Boston Scientific Corp | 1997 | — |
| −1 | K170726 | Biopsy Forceps | Fehling Instruments GmbH & Co. KG | 2017 | — |
| 0 (this device) | K252722 | Biopsy Forceps | Fehling Instruments GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 DWZ? 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? (1)
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 |
|---|---|---|---|
| * | K170726 | Biopsy ForcepsSummary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K170726 1 1 Biopsy Forceps I I Dwz Device Descriptio… | 2017 |
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 38 years and passes through 4 companies; a new generation was cleared every 10.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DWZ devicesDWZ Device, Biopsy, Endomyocardial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWZ
Too few DWZ 510(k)s in any year since 2007 to give a median.
Recalls per year · DWZ
No recall names DWZ since 2007.
Adverse event reports per year · DWZ
1in 2025
MAUDE reports naming product code DWZ, 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 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FEHLING Biopsy Forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252722: Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252722
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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