510(k) Report

510(k) · Cleared

Cleared

Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System (260-U and 261-U)

K965239510(k) TraditionalCleared Mar 28, 199787-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

Accutron, Inc. · CBN Apparatus, Gas-Scavenging

Cleared on Mar 28, 1997 after an 87-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Mar 28, 1997
Review
87 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2010: 1 descendant cleared1995200020052010201520202025
  1. This deviceK965239 Pip Low Profile Scavenging System (260 and 261)/Universal Low…Accutron, Inc. · 1997
  2. Descendant · cites it directly · 2 of its ownK033503 RFS Vacuum Gauge Scavenging CircuitAccutron, Inc. · 2004
  3. Descendant · 2 generations on · 1 of its ownK033028 Anefin, Model 100Axon Medical · 2005
  4. Descendant · 3 generations on · 0 of its ownK092031 Vapor-Clear, Model 100Axon Medical, Inc. · 2010 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K033503RFS Vacuum Gauge Scavenging CircuitAccutron, Inc. · 2004 · cites it directly2descendants
  • K033028Anefin, Model 100Axon Medical · 2005 · 2 generations on1descendant
  • K092031Vapor-Clear, Model 100Axon Medical, Inc. · 2010 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K965239Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile…Accutron, Inc.1997—
+1K033503RFS Vacuum Gauge Scavenging CircuitAccutron, Inc.2004—
+2K033028Anefin, Model 100Axon Medical2005—
+3K092031Vapor-Clear, Model 100Axon Medical, Inc.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
201010
FIG. 1 — Lineage of K965239, 1997–2010Source: FDA 510(k) summaries, read by 510(k) Report · 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 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 5.3 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K033503RFS Vacuum Gauge Scavenging CircuitAccutron, Inc.20042

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, K033503 (Accutron, Inc., 2004) has gone furthest, with 2 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—

More from Accutron, Inc.

5 FDA decisions under this applicant name. See the company

  • K052335Analgesia Gas Machine, Model Digital UltraAccutron, Inc. · 20054 Class I recalls
  • K033503RFS Vacuum Gauge Scavenging CircuitAccutron, Inc. · 2004
  • K992421Guardian Low Pressure Alarm Accessory, Model 34076Accutron, Inc. · 1999
  • K970046Universal Low Profile Nasal Hoods (1250,1275,1350,1450,1475,1550)Accutron, Inc. · 1997

Recent decisions in CBN

The CBN category page

  • K223452Nitronox Scavenger PlusParker Hannifin Corporation · 2023
  • K193646Dynamic Gas Scavenging System 2 (DGSS - 2)Anesthetic Gas Reclamation, Inc. · 2020
  • K160950MiniscavSedation Systems, LLC · 20171 recall
  • K142138Iso-Gard MaskTeleflexmedical, Inc. · 2014
  • K132729Iso-Gard MaskTeleflexmedical, Inc. · 2014

https://510kreport.com/device/K965239 · printed Nov 5, 2026

Cite this page

510(k) Report. “K965239: Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System (260-U and 261-U).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965239

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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