510(k) · Cleared
ClearedSklarlite Rigid Sterilization Container System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sklar Corp. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Apr 9, 2010 as substantially equivalent to K050570 (Miltex, Inc., 2005) after a 302-day review. Its family tree reaches back 4 generations to 2000. 6 later devices descend from it.
- Decided
- Apr 9, 2010
- Review
- 302 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991023 (2000). 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK991023 Steritite Perforated Bottom Rigid Reusable Sterilization Container…Case Medical, Inc. · 2000
- 3 generations backK012931 Genesis Sterrad Compatible Reusable Sterilization Container SystemAllegiance Healthcare Corp. · 2002
- 2 generations backK023614 Steritite Rigid Reusable Sterilization Container SystemCase Medical, Inc. · 2003 · Recalled
- 1 generation backK050570 Miltex Rigid Sterilization Container SystemMiltex, Inc. · 2005
- This deviceK091720 Sklarlite Rigid Sterilization Container SystemSklar Corp. · 2010
- Descendant · cites it directly · 3 of its ownK102146 Bahadir Sterilization TraysBahadir USA Corp. · 2010 · Recalled
- Descendant · 2 generations on · 2 of its ownK112090 Bahadir Sterilization TraysBahadir USA Corp. · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK131407 Bahadir Sterilization TraysBahadir USA Corp. · 2014
- Descendant · cites it directly · 1 of its ownK123234 Ermis Sterilization Container SystemErmis Medizintechnik · 2013
- Descendant · 2 generations on · 0 of its ownK233578 Bahadir Sterilization ContainersBahadir USA, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102146Bahadir Sterilization TraysBahadir USA Corp. · 2010 · cites it directly3descendants
- K112090Bahadir Sterilization TraysBahadir USA Corp. · 2012 · 2 generations on2descendants
- K131407Bahadir Sterilization TraysBahadir USA Corp. · 2014 · cites it directly1descendant
- K123234Ermis Sterilization Container SystemErmis Medizintechnik · 2013 · cites it directly1descendant
- K233578Bahadir Sterilization ContainersBahadir USA, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991023 | Steritite Perforated Bottom Rigid Reusable Sterilization Container System with… | Case Medical, Inc. | 2000 | — |
| −3 | K012931 | Genesis Sterrad Compatible Reusable Sterilization Container System | Allegiance Healthcare Corp. | 2002 | — |
| −2 | K023614 | Steritite Rigid Reusable Sterilization Container System | Case Medical, Inc. | 2003 | 1 |
| −1 | K050570 | Miltex Rigid Sterilization Container System | Miltex, Inc. | 2005 | — |
| 0 (this device) | K091720 | Sklarlite Rigid Sterilization Container System | Sklar Corp. | 2010 | — |
| +1 | K102146 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2010 | 1 |
| +2 | K112090 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2012 | 1 |
| +1 | K131407 | Bahadir Sterilization Trays | Bahadir USA Corp. | 2014 | — |
| +1 | K123234 | Ermis Sterilization Container System | Ermis Medizintechnik | 2013 | — |
| +2 | K233578 | Bahadir Sterilization Containers | Bahadir USA, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
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 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? (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 | Decided |
|---|---|---|---|
| * | K050570 | Miltex Rigid Sterilization Container SystemSummary page 1…ual Name: Closed Sterilization Container 4. Predicate Device Information Miltex Rigid Sterilization Container System, Miltex, Incorporated, K050570 5. Device Description The SklarLite Rigid Sterilization Container System consists of a family of ri… | 2005 |
What descends from it? (6)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K102146 (Bahadir USA Corp., 2010) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K050570.
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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The SklarLiteTm Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270'F for 4 minutes with 30 minutes (minimum) dry time. The containers have been validated for sterilization of up to two instruments with lumens no…
Read the full statement (200 words)
The SklarLiteTm Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270'F for 4 minutes with 30 minutes (minimum) dry time.
The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) container. Containers have been validated for a combined maximum load of 25lbs. with up to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6)months.
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/K091720 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091720: Sklarlite Rigid Sterilization Container System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091720
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