510(k) Report

510(k) · Cleared

Cleared

Oropharyngeal Suction Airway

K770600510(k) TraditionalCleared Apr 8, 197710-day reviewClass I21 CFR 872.6640

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

W.H. Wall, D.D.S. · EBR Unit, Suction Operatory

Cleared on Apr 8, 1977 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 8, 1977
Review
10 days
Class
Class I
Product code
EBR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770600Source: 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 EBR devices

EBR Unit, Suction Operatory: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBR

FDA has decided no EBR device since 2007.

Median 510(k) review, days · EBR

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

Recalls per year · EBR

No recall names EBR since 2007.

Adverse event reports per year · EBR

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2025

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

Recent decisions in EBR

The EBR category page

  • K925367A-Dec 7284 Cuspidor, CascadeA-Dec, Inc. · 1994
  • K860058DenpaxNissho Iwai American Corp. · 1986

https://510kreport.com/device/K770600 · printed Nov 6, 2026

Cite this page

510(k) Report. “K770600: Oropharyngeal Suction Airway.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770600

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