510(k) Report

510(k) · Cleared

Cleared

Minrad Inc. Nasal Scavenging Circuit

K072255510(k) TraditionalCleared Oct 18, 200766-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

Minrad, Inc. · CBN Apparatus, Gas-Scavenging

Cleared on Oct 18, 2007 as substantially equivalent to K833692 (Fraser Harlake, Inc., 1983) after a 66-day review. Its family tree reaches back 1 generation to 1983.

Decided
Oct 18, 2007
Review
66 days
Class
Class II
Product code
CBN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K833692 (1983). No later device cites it as a predicate yet.

K833692 · Fraser Harlake Dental Anti-Polution Sys · Fraser Harlake, Inc. · 1983198019851990199520002005
  1. Root · 1 generation backK833692 Fraser Harlake Dental Anti-Polution SysFraser Harlake, Inc. · 1983
  2. This deviceK072255 Minrad Inc. Nasal Scavenging CircuitMinrad, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K833692Fraser Harlake Dental Anti-Polution SysFraser Harlake, Inc.1983—
0 (this device)K072255Minrad Inc. Nasal Scavenging CircuitMinrad, Inc.2007—
FIG. 1 — Lineage of K072255, 1983–2007Source: 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K833692Fraser Harlake Dental Anti-Polution Sys
Summary page 1
…tus (21 CFR 868.5430, Product Code CBN) 7. Predicate device: Fraser Harlake Dental Anti-Pollution System (K833692) 8. Description of device: The single-use Nasal Scavenging Circuit is designed for the…
Fraser Harlake, Inc.1983—

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.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All CBN devices

CBN Apparatus, Gas-Scavenging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The single-use Nasal Scavenging Circuit is intended to be used in conjunction with a

conscious sedation system for the delivery of medical gases to the patient, and for the

removal of expired, excess and unused gases from the treatment location.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072255: Minrad Inc. Nasal Scavenging Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072255

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026