510(k) Report

510(k) · Cleared

Cleared

Key Drill

K821127510(k) TraditionalCleared Jun 3, 198244-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

Key Medical, Inc. · GFG Bit, Surgical

Cleared on Jun 3, 1982 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 3, 1982
Review
44 days
Class
Class I
Product code
GFG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K821127Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 GFG? 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
Get a 510(k) Report

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 GFG devices

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

FDA decisions per year · GFG

FDA has decided no GFG device since 2007.

Median 510(k) review, days · GFG

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

Recalls per year · GFG

No recall names GFG since 2007.

Adverse event reports per year · GFG

110in 2025

2010: 52011: 142012: 132013: 262014: 102015: 182016: 122017: 282018: 222019: 202020: 522021: 682022: 692023: 522024: 792025: 110
2007high 110 (2025) · low 0 (2007)2025

MAUDE reports naming product code GFG, 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—00
20080—00
20090—00
20100—05
20110—014
20120—013
20130—026
20140—010
20150—018
20160—012
20170—028
20180—022
20190—020
20200—052
20210—068
20220—069
20230—052
20240—079
20250—0110
20260—0—

More from Key Medical, Inc.

4 FDA decisions under this applicant name. See the company

  • K812760HI-Temp Cardiovascular CauteryKey Medical, Inc. · 1982
  • K812644Replaceable Battery Perfectemp 2 CautKey Medical, Inc. · 1981
  • K810909Micro CauteryKey Medical, Inc. · 1981

Recent decisions in GFG

The GFG category page

  • K935225Mitek Modular Drill BitMitek Surgical Products, Inc. · 1994
  • K821486Micro DrillsSpire Medical, Inc. · 1982

https://510kreport.com/device/K821127 · printed Nov 5, 2026

Cite this page

510(k) Report. “K821127: Key Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K821127

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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