510(k) Report

510(k) · Cleared

Cleared

Biovac: Lfa Laser Fume (Smoke) Evacuatio

K790877510(k) TraditionalCleared May 23, 197916-day reviewClass I21 CFR 888.4220

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

Stackhouse Assoc. · JDY Evacuator, Vapor, Cement Monomer

Cleared on May 23, 1979 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 23, 1979
Review
16 days
Class
Class I
Product code
JDY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790877Source: 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 JDY? 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
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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 JDY devices

JDY Evacuator, Vapor, Cement Monomer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDY

FDA has decided no JDY device since 2007.

Median 510(k) review, days · JDY

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

Recalls per year · JDY

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JDY

2in 2025

2010: 22012: 22013: 12016: 12017: 32018: 12019: 22022: 12023: 12024: 22025: 2
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code JDY, 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—10
20090—00
20100—02
20110—00
20120—02
20130—01
20140—00
20150—00
20160—01
20170—03
20180—01
20190—02
20200—00
20210—00
20220—01
20230—01
20240—02
20250—02
20260—0—

More from Stackhouse Assoc.

5 FDA decisions under this applicant name. See the company

  • K912651Airsafe Minivac Smoke Filtration SystemStackhouse Assoc. · 1991
  • K910515Freedom Mark Iii Surgical Helmet SystemStackhouse Assoc. · 199115 recalls
  • K874512Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
  • K872935Anti-Infection ShieldStackhouse Assoc. · 1987

Recent decisions in JDY

The JDY category page

  • K902167Contain (TM) Laser Plume FilterArbor Technologies, Inc. · 1991
  • K902056Laser Trap 100 Laser Plume Smoke Evacuation FilterHollister, Inc. · 1990
  • K862509Charcoal Laser Smoke Filter Catalog NO. 901103-000Lifestream Int'L, Inc. · 1986
  • K810542Cement Fume Evacuator Tank & FilterWalgen Medical Innoventions · 1981
  • K780202Monomer Evacuation SystemMedishield, Inc. · 1978

https://510kreport.com/device/K790877 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790877: Biovac: Lfa Laser Fume (Smoke) Evacuatio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790877

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