510(k) Report

510(k) · Cleared

Cleared

Padgett Air Dermatome, Model a

K951085510(k) TraditionalCleared May 15, 199567-day reviewClass I21 CFR 878.4820

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

Padgett Instruments, Inc. · GFD Dermatome

Cleared on May 15, 1995 after a 67-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 15, 1995
Review
67 days
Class
Class I
Product code
GFD
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K951085Source: 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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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?

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 GFD devices

GFD Dermatome: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFD

FDA has decided no GFD device since 2007.

Median 510(k) review, days · GFD

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

Recalls per year · GFD

2in 2025

2011: 12014: 12016: 12023: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · GFD

744in 2025

2007: 302008: 322009: 2662010: 1692011: 2262012: 2582013: 5582014: 3652015: 1952016: 1252017: 3242018: 3782019: 4722020: 4332021: 6142022: 5452023: 8062024: 7962025: 744
2007high 806 (2023) · low 30 (2007)2025

MAUDE reports naming product code GFD, 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—030
20080—032
20090—0266
20100—0169
20110—1226
20120—0258
20130—0558
20140—1365
20150—0195
20160—1125
20170—0324
20180—0378
20190—0472
20200—0433
20210—0614
20220—0545
20230—1806
20240—0796
20250—2744
20260—0—

More from Padgett Instruments, Inc.

2 FDA decisions under this applicant name. See the company

  • K770970Hair Transplant Punch, MultiplhPadgett Instruments, Inc. · 1977

Recent decisions in GFD

The GFD category page

  • K965256DMS-1000C DermoabraderMattioli Engineering, Srl · 1996
  • K962371Dermtome BladeDsp Worldwide · 1996
  • K945594Deca Dermatome (Micromotor System)Depuy Intl., Ltd. · 1995
  • K940208Aesculap Accu-DermatomeAesculap, Inc. · 1994
  • K862669Activated Partial Thromboplastin Time TestU. S. Diagnostics, Inc. · 1986

https://510kreport.com/device/K951085 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951085: Padgett Air Dermatome, Model a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951085

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