510(k) Report

510(k) · Cleared

Cleared

Filter System, Altner Disposable

K790209510(k) TraditionalCleared Feb 26, 197927-day reviewClass II21 CFR 880.6740

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

Orthopedic Equipment Co., Inc. · GAZ Tubing, Noninvasive

Cleared on Feb 26, 1979 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 26, 1979
Review
27 days
Class
Class II
Product code
GAZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790209Source: 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 GAZ? 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 GAZ devices

GAZ Tubing, Noninvasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAZ

FDA has decided no GAZ device since 2007.

Median 510(k) review, days · GAZ

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

Recalls per year · GAZ

1in 2017

2008: 12010: 102016: 12017: 1
2007high 10 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GAZ

42in 2025

2007: 12010: 12011: 12012: 22013: 22014: 52015: 12016: 152017: 92018: 102019: 232020: 252021: 182022: 122023: 242024: 652025: 42
2007high 65 (2024) · low 0 (2008)2025

MAUDE reports naming product code GAZ, 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—01
20080—10
20090—00
20100—101
20110—01
20120—02
20130—02
20140—05
20150—01
20160—115
20170—19
20180—010
20190—023
20200—025
20210—018
20220—012
20230—024
20240—065
20250—042
20260—0—

More from Orthopedic Equipment Co., Inc.

45 FDA decisions under this applicant name. See the company

  • K834035Universal Self-Aligning Acetabular ComOrthopedic Equipment Co., Inc. · 1984
  • K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  • K800530Schlein Tri-Surface AnkleOrthopedic Equipment Co., Inc. · 1980
  • K781445SpreaderOrthopedic Equipment Co., Inc. · 1979
  • K790247Tourniquet Test GageOrthopedic Equipment Co., Inc. · 1979

Recent decisions in GAZ

The GAZ category page

  • K952605Suction/Irrigator Tubing KitSurgical Laser Technologies, Inc. · 1995
  • K945978Tubing, NoninvasiveEndoscopic Technologies, Inc. · 1995
  • K930512Suction/Irrigation Y Tubing Set W/Trumpet ValvesCore Dynamics, Inc. · 19931 recall
  • K911865Nortec Connecting Tube SetNorth American Sterilization & Packaging Co. · 1991
  • K910471Medid-Vac Clear Nonconductive Connecting TubeBaxter Healthcare Corp · 1991

https://510kreport.com/device/K790209 · printed Nov 4, 2026

Cite this page

510(k) Report. “K790209: Filter System, Altner Disposable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K790209

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