510(k) · Cleared
Recalled · 2011Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Custom Mfg., Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on May 6, 1997 after a 438-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it. It has been recalled once.
- Decided
- May 6, 1997
- Review
- 438 days
- Class
- Class II
- Product code
- KCT
- Recalls
- 1
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK960738 Steritite Sealed Container…Engineered Custom Mfg., 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
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) | K960738 | Steritite Sealed Container… | Engineered Custom Mfg., 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 |
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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (26)
See all 262 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2011 | Not classified | Z-2612-2011 | Nonconforming Material/Component | During testing and review, Stryker Endoscopy discovered that the sterilization parameters for the 132 degree C gravity steam sterilization cycle in the IFU may not consistently sterilize all instruments in the 45cm Laparoscopic… |
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 KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
https://510kreport.com/device/K960738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960738: Steritite Sealed Container (SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960738
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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