510(k) · Cleared

Cleared

Steritite Sealed Containers Model SCO4Q

K974638510(k) TraditionalCleared Dec 18, 199769-day reviewClass II21 CFR 880.6850

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

Case Medical, Inc. · FRG Wrap, Sterilization

Cleared on Dec 18, 1997 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it.

Decided: Dec 18, 1997
Review: 69 days
Class: Class II
Product code: FRG
Recalls: None
Predicates: 0

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

This deviceK974638 Steritite Sealed Containers Model SCO4QCase Medical, Inc. · 1997
Descendant · cites it directly · 25 of its ownK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
Descendant · 2 generations on · 12 of its ownK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
Descendant · 3 generations on · 9 of its ownK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
Descendant · 3 generations on · 7 of its ownK112671 Sterilcontainer SystemAesculap, Ltd. · 2012
Descendant · 2 generations on · 7 of its ownK072563 Miltex Rigid Container SystemsMiltex, Inc. · 2008

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2003high 3 (2006) · low 0 (2004)2026

Most influential descendants

Showing 5 of 26 · See all

K022978Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003 · cites it directly25descendants
K053389Aesculap Sterilcontainer SystemAesculap, Inc. · 2006 · 2 generations on12descendants
K073168Aesculap Primeline Container LTD.Aesculap, Inc. · 2008 · 3 generations on9descendants
K112671Sterilcontainer SystemAesculap, Ltd. · 2012 · 3 generations on7descendants
K072563Miltex Rigid Container SystemsMiltex, Inc. · 2008 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K974638	Steritite Sealed Containers Model SCO4Q	Case Medical, Inc.	1997	—
+1	K022978	Steritite Container with Flashtite Valve Plate (S) & Meditray Products	Case Medical, Inc.	2003	—
+2	K053389	Aesculap Sterilcontainer System	Aesculap, Inc.	2006	—
+3	K073168	Aesculap Primeline Container LTD.	Aesculap, Inc.	2008	—
+3	K112671	Sterilcontainer System	Aesculap, Ltd.	2012	—
+2	K072563	Miltex Rigid Container Systems	Miltex, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	3	0
2008	2	0
2010	2	0
2012	3	0
2014	1	0
2016	1	0
2017	1	0
2018	1	0
2020	2	0
2022	3	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K974638, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in FRG? 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 FRG device

#1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K022978	Steritite Container with Flashtite Valve Plate (S) & Meditray Products	Case Medical, Inc.	2003	25

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, K022978 (Case Medical, Inc., 2003) has gone furthest, with 25 descendants of its own.

How does its category compare?

All FRG devices

FRG Wrap, Sterilization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRG

9in 2025

2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2007high 29 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FRG

18in 2025

2007high 22 (2018) · low 0 (2010)2025

MAUDE reports naming product code FRG, 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	3	182	0	1
2008	2	—	0	2
2009	4	171	0	2
2010	4	213	0	0
2011	6	110	0	12
2012	10	133	0	4
2013	6	146	2	5
2014	8	177	0	13
2015	12	196	0	9
2016	9	131	0	20
2017	9	260	29	7
2018	5	150	0	22
2019	9	258	0	10
2020	5	122	14	21
2021	4	170	0	9
2022	9	217	2	4
2023	9	230	0	13
2024	11	182	0	21
2025	9	151	0	18
2026	4	247	0	—

What is it indicated for?

The SteriTite & product line is a Reusable Rigid Sterilization Container system intended to be used for the sterilization of surgical instruments for a hospital or other health care institution.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974638 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974638: Steritite Sealed Containers Model SCO4Q.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974638

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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