Trauma Pad 5 X 9

K940348510(k) TraditionalCleared Feb 25, 199431-day reviewClass U

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

Certified Safety Mfg., Inc. · EFQ Gauze/Sponge, Internal

Cleared on Feb 25, 1994 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided: Feb 25, 1994
Review: 31 days
Class: Class U
Product code: EFQ
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 K940348Source: FDA 510(k) database · How lineage is built

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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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?

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 EFQ devices

EFQ Gauze/Sponge, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFQ

FDA has decided no EFQ device since 2007.

Median 510(k) review, days · EFQ

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

Recalls per year · EFQ

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · EFQ

51in 2025

2007high 53 (2016) · low 0 (2008)2025

MAUDE reports naming product code EFQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	4
2008	—	0	0
2009	—	0	4
2010	—	0	9
2011	—	0	6
2012	—	0	9
2013	—	0	8
2014	—	0	11
2015	—	0	27
2016	—	0	53
2017	—	0	8
2018	—	0	7
2019	—	0	5
2020	—	1	8
2021	—	0	6
2022	—	1	6
2023	—	0	10
2024	—	0	8
2025	—	0	51
2026	—	3	—

https://510kreport.com/device/K940348 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940348: Trauma Pad 5 X 9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940348

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Record history

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