510(k) · Cleared

Cleared

Barrier All Film

K952234510(k) TraditionalCleared Jul 31, 199580-day reviewClass I21 CFR 872.6510

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

Cottrell, Ltd. · EFS Unit, Oral Irrigation

Cleared on Jul 31, 1995 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jul 31, 1995
Review: 80 days
Class: Class I
Product code: EFS
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK952234 Barrier All FilmCottrell, Ltd. · 1995
Descendant · cites it directly · 1 of its ownK963664 Dental Handpiece and AccessoryFilmtech, Inc. · 1996
Descendant · 2 generations on · 0 of its ownK031851 Dentiseptic HPCBethel, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K963664Dental Handpiece and AccessoryFilmtech, Inc. · 1996 · cites it directly1descendant
K031851Dentiseptic HPCBethel, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K952234	Barrier All Film	Cottrell, Ltd.	1995	—
+1	K963664	Dental Handpiece and Accessory	Filmtech, Inc.	1996	—
+2	K031851	Dentiseptic HPC	Bethel, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2003	1	0

FIG. 1 — Lineage of K952234, 1995–2003Source: FDA 510(k) summaries, read by 510(k) Report · 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.

Planning a device in EFS? 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K963664	Dental Handpiece and Accessory	Filmtech, Inc.	1996	1

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.

What does this lineage say?

Of its descendants, K963664 (Filmtech, Inc., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All EFS devices

EFS Unit, Oral Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFS

FDA has decided no EFS device since 2007.

Median 510(k) review, days · EFS

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

Recalls per year · EFS

No recall names EFS since 2007.

Adverse event reports per year · EFS

9in 2025

2007high 34 (2023) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	2
2013	—	0
2014	—	0
2015	—	7
2016	—	6
2017	—	7
2018	—	13
2019	—	6
2020	—	16
2021	—	18
2022	—	21
2023	—	34
2024	—	31
2025	—	9
2026	—	—

https://510kreport.com/device/K952234 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952234: Barrier All Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952234

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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