510(k) Report

510(k) · Cleared

Cleared

Nail Set

K872388510(k) TraditionalCleared Jul 23, 198734-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

Med-Tool, Inc. · LRY Punch, Surgical

Cleared on Jul 23, 1987 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 23, 1987
Review
34 days
Class
Class I
Product code
LRY
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K872388Source: FDA 510(k) database · 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.

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  • 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?

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.

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 Med-Tool, Inc.

28 FDA decisions under this applicant name. See the company

  • K874357Tapered PunchMed-Tool, Inc. · 1987
  • K874359Adjustable WrenchesMed-Tool, Inc. · 1987
  • K874356Pin PunchMed-Tool, Inc. · 1987
  • K874358Combination WrenchesMed-Tool, Inc. · 1987
  • K872387Standard Screw DriverMed-Tool, Inc. · 1987

Recent decisions in LRY

The LRY category page

  • K933516Acu-E PunchAcuderm, Inc. · 1994
  • K904869Ellipse PunchKramer Const · 1991
  • K902636Lipogen Rheumelisa Dsdna AssayLipogen, Inc. · 1990
  • K896303Biopsy PunchPremier Medical · 1990
  • K874356Pin PunchMed-Tool, Inc. · 1987

https://510kreport.com/device/K872388 · printed Nov 4, 2026

Cite this page

510(k) Report. “K872388: Nail Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872388

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