510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Suction/Irrigation Y Tubing Set W/Trumpet Valves

K930512510(k) TraditionalCleared Jul 23, 1993172-day reviewClass II21 CFR 880.6740Recalls 1

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

Core Dynamics, Inc. · GAZ Tubing, Noninvasive

Cleared on Jul 23, 1993 after a 172-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jul 23, 1993
Review
172 days
Class
Class II
Product code
GAZ
Recalls
1
Predicates
0

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

Descendants, by year cleared 2015: 1 descendant cleared1990200020102020
  1. This deviceK930512 Suction/Irrigation Y Tubing Set W/Trumpet ValvesCore Dynamics, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK151822 ab medica irrigation/suction gravity systemAb Medica Sas · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K151822ab medica irrigation/suction gravity systemAb Medica Sas · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930512Suction/Irrigation Y Tubing Set W/Trumpet ValvesCore Dynamics, Inc.1993—
+1K151822ab medica irrigation/suction gravity systemAb Medica Sas2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K930512, 1993–2015Source: 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 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 lists a 510(k) statement for it but has not posted the file, 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
K151822ab medica irrigation/suction gravity systemAb Medica Sas20150

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 27, 2016Class IIZ-0131-2017Under Investigation by firmThe packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K151822 (Ab Medica Sas, 2015) has gone furthest, with 0 descendants of its own.

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 Core Dynamics, Inc.

23 FDA decisions under this applicant name. See the company

  • K992250Core Audible Trocar IICore Dynamics, Inc. · 1999
  • K992190Core PouchCore Dynamics, Inc. · 1999
  • K955490Laparoscopic KnitterCore Dynamics, Inc. · 1996
  • K953903Laparoscopic Trocar Obturator, 5MM, 10/11MM, 10/12MMCore Dynamics, Inc. · 1995
  • K953409Laparoscopic TrocarCore Dynamics, Inc. · 1995

Recent decisions in GAZ

The GAZ category page

  • K952605Suction/Irrigator Tubing KitSurgical Laser Technologies, Inc. · 1995
  • K945978Tubing, NoninvasiveEndoscopic Technologies, Inc. · 1995
  • K911865Nortec Connecting Tube SetNorth American Sterilization & Packaging Co. · 1991
  • K910471Medid-Vac Clear Nonconductive Connecting TubeBaxter Healthcare Corp · 1991
  • K910171Maxi-Flow Suction Set W/Y ConnectorAdler Instrument Co. · 1991

https://510kreport.com/device/K930512 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930512: Suction/Irrigation Y Tubing Set W/Trumpet Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930512

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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