510(k) Report

510(k) · Cleared

Cleared

Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl

K991023510(k) TraditionalCleared Jan 27, 2000304-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 Jan 27, 2000 after a 304-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.

Decided
Jan 27, 2000
Review
304 days
Class
Class II
Product code
FRG
Recalls
None
Predicates
0

21 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2017: 1 descendant cleared2003: 2 descendants cleared2012: 2 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared2015: 2 descendants cleared2014: 3 descendants cleared2010: 2 descendants cleared2019: 1 descendant cleared2013: 1 descendant cleared2016: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant clearedReference device: K960738 · Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H) · Engineered Custom Mfg., Inc. · 1997 · recalled200020052010201520202025
  1. This deviceK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
  2. Descendant · cites it directly · 18 of its ownK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
  3. Descendant · 2 generations on · 9 of its ownK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 7 of its ownK112535 Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012
  5. Descendant · 3 generations on · 7 of its ownK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
  6. Descendant · 4 generations on · 6 of its ownK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22005: 12006: 12010: 22012: 22013: 12014: 32015: 22016: 22017: 12018: 12019: 12024: 1
2002high 3 (2014) · low 0 (2004)2026

Most influential descendants

Showing 5 of 21 · See all
  • K012931Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002 · cites it directly18descendants
  • K023614Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · 2 generations on9descendants
  • K112535Genesis Reusable Rigid Container SystemCarefusion 2200, Inc. · 2012 · 2 generations on7descendants
  • K050570Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005 · 3 generations on7descendants
  • K091720Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K991023Steritite Perforated Bottom Rigid Reusable Sterilization Container System with…Case Medical, Inc.2000—
+1K012931Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp.2002—
+2K023614Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc.20031
+2K112535Genesis Reusable Rigid Container SystemCarefusion 2200, Inc.2012—
+3K050570Miltex Rigid Sterilization Container SystemMiltex, Inc.2005—
+4K091720Sklarlite Rigid Sterilization Container SystemSklar Corp.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200510
200610
201020
201220
201310
201430
201520
201620
201710
201810
201910
202410
FIG. 1 — Lineage of K991023, 2000–2024Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 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. #1 K234050 HALYARD® ONE-STEP® Sterilization Wrap…score 15.8 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—Spunguard wrap/SteriTite® Container System
Named without a submission number
—
†K960738Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)Engineered Custom Mfg., Inc.19971

What descends from it? (21)

See all 21

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012931Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp.200218
K030853Steritite Perforated Base Rigid Reusable Sterilization Container System with…Case Medical, Inc.20031
K161415SteriTite Containers System & MediTray ProductsCase Medical, Inc.20170

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, K012931 (Allegiance Healthcare Corp., 2002) has gone furthest, with 18 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

2007: 32008: 22009: 42010: 42011: 62012: 102013: 62014: 82015: 122016: 92017: 92018: 52019: 92020: 52021: 42022: 92023: 92024: 112025: 92026 (partial year): 4
2007high 12 (2015) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRG

151in 2025

2007: 182 days median2009: 171 days median2010: 213 days median2011: 110 days median2012: 133 days median2013: 146 days median2014: 177 days median2015: 196 days median2016: 131 days median2017: 260 days median2018: 150 days median2019: 258 days median2020: 122 days median2021: 170 days median2022: 217 days median2023: 230 days median2024: 182 days median2025: 151 days median2026 (partial year): 247 days median
2007high 260 (2017) · low 110 (2011)2026

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

Recalls per year · FRG

2in 2022

2013: 22017: 292020: 142022: 2
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

2007: 12008: 22009: 22011: 122012: 42013: 52014: 132015: 92016: 202017: 72018: 222019: 102020: 212021: 92022: 42023: 132024: 212025: 18
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007318201
20082—02
2009417102
2010421300
20116110012
20121013304
2013614625
20148177013
20151219609
20169131020
20179260297
20185150022
20199258010
202051221421
2021417009
2022921724
20239230013
202411182021
20259151018
202642470—

What is it indicated for?

The perforated base containers are part of the SteriTite® Reusable Rigid Sterilization Container system.

The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100 Sterilization for a hospital or other health care facilities.

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

More from Case Medical, Inc.

15 FDA decisions under this applicant name. See the company

  • K252854SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2026
  • K221492SteriTite Container System with MediTray PartsCase Medical, Inc. · 2022
  • K212711SteriTite Container System with MediTray ProductsCase Medical, Inc. · 2022
  • K173259Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessoriesCase Medical, Inc. · 2018
  • K161415SteriTite Containers System & MediTray ProductsCase Medical, Inc. · 2017

Recent decisions in FRG

The FRG category page

  • K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap…O&M Halyard, Inc. · 2026
  • K252823Dukal Crepe Paper Sterilization WrapDukal, LLC · 2026
  • K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL…O&M Halyard, Inc. · 2026
  • K251347Sterilization Pouch/RollSterivic Medical Co., Ltd. · 2026
  • K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd. · 2025

https://510kreport.com/device/K991023 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991023: Steritite Perforated Bottom Rigid Reusable Sterilization Container System with SCF02 - Polypropylene Non-Woven Disposabl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991023

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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