510(k) Report

510(k) · Cleared

Cleared

Biopsy Punch

K896303510(k) TraditionalCleared Feb 13, 1990106-day reviewClass I21 CFR 878.4800

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

Premier Medical · LRY Punch, Surgical

Cleared on Feb 13, 1990 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 13, 1990
Review
106 days
Class
Class I
Product code
LRY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK896303 Biopsy PunchPremier Medical · 1990
  2. Descendant · cites it directly · 1 of its ownK080095 Coramate/Spirotome SystemMedinvents · 2008 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK190378 Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14…Bioncise NV · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K080095Coramate/Spirotome SystemMedinvents · 2008 · cites it directly1descendant
  • K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…Bioncise NV · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K896303Biopsy PunchPremier Medical1990—
+1K080095Coramate/Spirotome SystemMedinvents20081
+2K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge…Bioncise NV2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201910
FIG. 1 — Lineage of K896303, 1990–2019Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LRY? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, 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
K080095Coramate/Spirotome SystemMedinvents20081

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, K080095 (Medinvents, 2008) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LRY devices

LRY Punch, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRY

FDA has decided no LRY device since 2007.

Median 510(k) review, days · LRY

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

Recalls per year · LRY

1in 2017

2016: 12017: 1
2007high 1 (2016) · low 0 (2007)2026

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

Adverse event reports per year · LRY

45in 2025

2007: 22008: 52009: 42010: 52011: 22012: 22013: 92014: 102015: 252016: 742017: 722018: 832019: 772020: 862021: 682022: 572023: 462024: 462025: 45
2007high 86 (2020) · low 2 (2007)2025

MAUDE reports naming product code LRY, 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—02
20080—05
20090—04
20100—05
20110—02
20120—02
20130—09
20140—010
20150—025
20160—174
20170—172
20180—083
20190—077
20200—086
20210—068
20220—057
20230—046
20240—046
20250—045
20260—0—

More from Premier Medical

3 FDA decisions under this applicant name. See the company

  • K894050Modified Decannulation StopperPremier Medical · 1989
  • K884418Premier Die-Trak ArticulatorPremier Medical · 1988

Recent decisions in LRY

The LRY category page

  • K933516Acu-E PunchAcuderm, Inc. · 1994
  • K904869Ellipse PunchKramer Const · 1991
  • K902636Lipogen Rheumelisa Dsdna AssayLipogen, Inc. · 1990
  • K874357Tapered PunchMed-Tool, Inc. · 1987
  • K874356Pin PunchMed-Tool, Inc. · 1987

https://510kreport.com/device/K896303 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896303: Biopsy Punch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896303

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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