510(k) Report

510(k) · Cleared

Cleared

Ultravac-NG (TM) Nasogastric Sump Suction Tube

K926073510(k) TraditionalCleared May 15, 1995895-day reviewClass II21 CFR 876.5980

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

Surgimark, Inc. · FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation

Cleared on May 15, 1995 after an 895-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 15, 1995
Review
895 days
Class
Class II
Product code
FEG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K926073Source: 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 lists a 510(k) statement for it but has not posted the file, 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 FEG devices

FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEG

1in 2017

2013: 12017: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEG

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

Recalls per year · FEG

2in 2025

2023: 102025: 2
2007high 10 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FEG

46in 2025

2008: 12009: 32010: 12012: 22013: 22014: 52015: 12016: 42017: 132018: 152019: 362020: 232021: 272022: 402023: 332024: 312025: 46
2007high 46 (2025) · low 0 (2007)2025

MAUDE reports naming product code FEG, 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—01
20090—03
20100—01
20110—00
20120—02
20131—02
20140—05
20150—01
20160—04
20171—013
20180—015
20190—036
20200—023
20210—027
20220—040
20230—1033
20240—031
20250—246
20260—0—

More from Surgimark, Inc.

3 FDA decisions under this applicant name. See the company

  • K932689Lapro-Loader (TM)Surgimark, Inc. · 1994
  • K871950Via-GuardSurgimark, Inc. · 1987

Recent decisions in FEG

The FEG category page

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  • K132314Medline Anti-Reflux ValveMedline Industries, Inc. · 2013
  • K053410Gientriport with Universal Single Lumen AdaptorKendall · 2006
  • K040388Next Generation Salem SumpKendall · 2004
  • K971354Knott NG TubeMichael M. Knott, M.D. · 1997

https://510kreport.com/device/K926073 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926073: Ultravac-NG (TM) Nasogastric Sump Suction Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926073

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