510(k) Report

510(k) · Cleared

Cleared

Dermabraders

K821485510(k) TraditionalCleared Jun 10, 198223-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

Spire Medical, Inc. · GFF Bur, Surgical, General & Plastic Surgery

Cleared on Jun 10, 1982 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 10, 1982
Review
23 days
Class
Class I
Product code
GFF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K821485Source: 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.

Planning a device in GFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 GFF devices

GFF Bur, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFF

FDA has decided no GFF device since 2007.

Median 510(k) review, days · GFF

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

Recalls per year · GFF

1in 2019

2007: 12008: 12011: 12012: 12016: 12019: 1
2007high 1 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GFF

72in 2025

2007: 32008: 92009: 32010: 242011: 252012: 272013: 8992014: 1162015: 1042016: 1052017: 832018: 832019: 802020: 232021: 762022: 682023: 962024: 1242025: 72
2007high 899 (2013) · low 3 (2007)2025

MAUDE reports naming product code GFF, 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—13
20080—19
20090—03
20100—024
20110—125
20120—127
20130—0899
20140—0116
20150—0104
20160—1105
20170—083
20180—083
20190—180
20200—023
20210—076
20220—068
20230—096
20240—0124
20250—072
20260—0—

More from Spire Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K821487Micro-Surgical Power Instrument Sys.Spire Medical, Inc. · 1982
  • K821486Micro DrillsSpire Medical, Inc. · 1982
  • K802503Micro-Sugical Power Instrument SystemSpire Medical, Inc. · 1980
  • K802463Micro-Surgical Power Instrument SystemSpire Medical, Inc. · 1980

Recent decisions in GFF

The GFF category page

  • K974025Anspach Shielded AttachmentThe Anspach Effort, Inc. · 199817 recalls
  • K950449Surgical BurTransidyne General Corp. · 1995
  • K943758Surgical BurKomet Medical · 1994
  • K934583BURRSAmerican Medical Specialties, Inc. · 1994
  • K894438Micro-Aire Cutters for Midas-Rex InstrumentsMicro-Aire Surgical Instruments, Inc. · 1989

https://510kreport.com/device/K821485 · printed Nov 5, 2026

Cite this page

510(k) Report. “K821485: Dermabraders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K821485

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