510(k) Report

510(k) · Cleared

Cleared

Cement-Pick

K822108510(k) TraditionalCleared Aug 11, 198223-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

Bio-Blitz, Inc. · GAF Spatula, Surgical, General & Plastic Surgery

Cleared on Aug 11, 1982 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 11, 1982
Review
23 days
Class
Class I
Product code
GAF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822108Source: 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 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 GAF devices

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

FDA decisions per year · GAF

FDA has decided no GAF device since 2007.

Median 510(k) review, days · GAF

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

Recalls per year · GAF

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · GAF

1in 2020

2011: 32012: 12015: 22018: 22020: 1
2007high 3 (2011) · low 0 (2007)2025

MAUDE reports naming product code GAF, 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—00
20110—03
20120—01
20130—00
20140—00
20150—02
20160—00
20170—00
20180—02
20190—00
20200—01
20210—00
20220—00
20230—00
20240—10
20250—00
20260—0—

More from Bio-Blitz, Inc.

2 FDA decisions under this applicant name. See the company

  • K822109Shovel RetractorBio-Blitz, Inc. · 1982

Recent decisions in GAF

The GAF category page

  • K023688Lemaitre Vascular Disposable Vein StripperLeMaitre Vascular, Inc. · 2003
  • K935357Snap Reciprocating SawSurgiquip, Inc. · 1994
  • K890374Abdominal SpatulaKinetic Medical Products · 1989
  • K882793PMT Fukushima Microsurgical Instrument LinePmt Corp. · 1988

https://510kreport.com/device/K822108 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822108: Cement-Pick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822108

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