510(k) Report

510(k) · Cleared

Cleared

Clean-Air Pollution Reduction System

K802067510(k) TraditionalCleared Sep 26, 198030-day reviewClass II21 CFR 868.5430

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

Porter Instrument Co., Inc. · CBN Apparatus, Gas-Scavenging

Cleared on Sep 26, 1980 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 26, 1980
Review
30 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared19801990200020102020
  1. This deviceK802067 Clean-Air Pollution Reduction SystemPorter Instrument Co., Inc. · 1980
  2. Descendant · cites it directly · 0 of its ownK981754 Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K802067Clean-Air Pollution Reduction SystemPorter Instrument Co., Inc.1980—
+1K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K802067, 1980–1998Source: FDA 510(k) summaries, read by 510(k) Report · 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 CBN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CBN device

  1. #1 K223452 Nitronox Scavenger Plusscore 5.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc.19980

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.

What does this lineage say?

  • Of its descendants, K981754 (Porter Instrument Co., Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CBN devices

CBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBN

1in 2023

2007: 12008: 12010: 12011: 12013: 12014: 22017: 12020: 12023: 1
2007high 2 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBN

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

Recalls per year · CBN

No recall names CBN since 2007.

Adverse event reports per year · CBN

1in 2025

2012: 12015: 12020: 22025: 1
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code CBN, 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
20071—00
20081—00
20090—00
20101—00
20111—00
20120—01
20131—00
20142—00
20150—01
20160—00
20171—00
20180—00
20190—00
20201—02
20210—00
20220—00
20231—00
20240—00
20250—01
20260—0—
Cite this page

510(k) Report. “K802067: Clean-Air Pollution Reduction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802067

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