510(k) · Cleared

Cleared

Sheer Thin

K984488510(k) TraditionalCleared Feb 1, 199946-day reviewClass II21 CFR 884.5300

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

Cleared on Feb 1, 1999 as substantially equivalent to K912901 (Carter Products, 1992) after a 46-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Feb 1, 1999
Review: 46 days
Class: Class II
Product code: HIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K912901 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK912901 Trojan (TM-TBD) CondomCarter Products · 1992
This deviceK984488 Sheer ThinTwe Companies, Inc. · 1999
Descendant · cites it directly · 0 of its ownK051273 Divas Dual Pleasure Male Latex CondomEagle Twe, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K051273Divas Dual Pleasure Male Latex CondomEagle Twe, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912901	Trojan (TM-TBD) Condom	Carter Products	1992	—
0 (this device)	K984488	Sheer Thin	Twe Companies, Inc.	1999	—
+1	K051273	Divas Dual Pleasure Male Latex Condom	Eagle Twe, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K984488, 1992–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HIS device

#1 K262108 FAMA Male Latex Condoms – Aqueous Lubricant…score 13.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K912901	Trojan (TM-TBD) Condom Summary page 1 …erson: Keith F. Heintz Date Prepared: December 16, 1998 Propri e: Sheer Thin Common Name: Latex Condom Classification Name: Condom redi vice: Trojan Ultra Thin 510(k) #K912901 Description of the Device: The condom is made of a natural rubber latex sheath, which completely covers the penis with a closel…	Carter Products	1992	—

Also cleared against K912901: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K051273	Divas Dual Pleasure Male Latex Condom	Eagle Twe, Inc.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K051273 (Eagle Twe, Inc., 2005) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K912901.

How does its category compare?

All HIS devices

HIS Condom: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIS

5in 2025

2007high 10 (2022) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIS

99in 2025

2007high 242 (2014) · low 54 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HIS

1in 2013

2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · HIS

20in 2025

2007high 22 (2010) · low 5 (2016)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	128	1	10
2008	3	157	0	11
2009	5	241	0	12
2010	1	—	0	22
2011	3	54	0	15
2012	7	106	1	10
2013	4	208	1	19
2014	7	242	0	16
2015	3	136	0	8
2016	5	115	0	5
2017	4	102	0	8
2018	2	—	0	11
2019	1	—	0	15
2020	4	240	0	12
2021	5	233	0	16
2022	10	112	0	18
2023	2	—	0	10
2024	0	—	0	7
2025	5	99	0	20
2026	2	—	0	—

What is it indicated for?

The Sheer Thin condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984488: Sheer Thin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984488

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026