510(k) · Cleared
ClearedSterilContainer with PrimeLine Pro Lid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Nov 17, 2017 as substantially equivalent to K073168 (Aesculap, Inc., 2008) after a 58-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Nov 17, 2017
- Review
- 58 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871202 (1987). 12 ancestors in all, the oldest K792558 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK871202 Flashpak Container SystemPerformance Instruments Corp. · 1987
- 3 generations backK022978 Steritite Container with Flashtite Valve Plate (S) & Meditray ProductsCase Medical, Inc. · 2003
- 2 generations backK053389 Aesculap Sterilcontainer SystemAesculap, Inc. · 2006
- 1 generation backK073168 Aesculap Primeline Container LTD.Aesculap, Inc. · 2008
- This deviceK172850 SterilContainer with PrimeLine Pro LidAesculap, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871202 | Flashpak Container System | Performance Instruments Corp. | 1987 | — |
| −3 | K022978 | Steritite Container with Flashtite Valve Plate (S) & Meditray Products | Case Medical, Inc. | 2003 | — |
| −2 | K053389 | Aesculap Sterilcontainer System | Aesculap, Inc. | 2006 | — |
| −1 | K073168 | Aesculap Primeline Container LTD. | Aesculap, Inc. | 2008 | — |
| 0 (this device) | K172850 | SterilContainer with PrimeLine Pro Lid | Aesculap, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 3 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K073168 | Aesculap Primeline Container LTD.Summary page 5…IFICATION NAME: Wrap, Sterilization REGULATION NUMBER: 880.6850 PRODUCT CODE: KCT PREDICATE DEVICES Primary Predicate : Primeline Lid (K073168) Reference Devices: Sterilcontainer System (K792558), Rigid Container System (K944864), and the SterilContainer System for Flash… | 2008 |
| † | K792558 | Container System | 1979 |
| † | K944864 | Primed Rigid Container System | 1994 |
| † | K053389 | Aesculap Sterilcontainer System | 2006 |
| † | K112671 | Sterilcontainer System | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K073168.
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. 2017, 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 Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This…
Read the full statement (447 words)
The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization) sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.
Table 1: Steam and IUSS Compatible SterilContainer with PrimeLine Pro Lid
A combined maximum load validated for all container configurations is 25lbs.
Sterilization Cycle Parameters: Immediate Use (Non porous), 270ºF Temp, 3 min. Exposure; No stacking recommended. Immediate Use (porous), 270ºF Temp, 4 min. Exposure; No stacking recommended. Prevacuum Dry Time Study, 270ºF Temp, 4min. Exposure, 30 min. Dry Time; Stacking should not exceed 16-18” height. Prevacuum Dry Time Study, 270ºF Temp, 4min. Exposure, 30 min. Dry Time; Stacking should not exceed 16-18” height.
PrimeLine Pro Lid with JP050 – Lid Size: ½ size Lid (298 x281 x36), Art. No. JP121 – JP125; ¾ size Lid (465 x 281 x 36), Art. No. JP111 – JP115; Full size Lid (588 x 281 x 36), Art. No. JP101 – JP105.
Solid Base to be used with Lid: JK340 (4-1/4 in height), JK341 (5-1/2 in height), JK342 (6 in height), JK344 (8 in height), JK346 (10-1/2 in height); JK740 (4-1/4 in height), JK741 (5-1/2 in height), JK742 (6 in height), JK744 (8 in height); JK440 (4-1/4 in height), JK441 (5-1/2 in height), JK442 (6 in height), JK444 (8 in height), JK446 (10-1/2 in height).
Max No. of Lumens Lumen Configuration: Immediate Use – Non Porous: No lumens, a hinged device, and a knurled (irregular surface) device. Immediate Use – Porous: 1 SS lumen with 3mm I.D. x 400mm L and a hinged device.
Perforated Base to be used with Lid: ½ size Lid: JN340 (4½ in height), JN341 (5½ in height), JN342 (6 in height), JN344 (8 in height), JN346 (10½ in height); ¾ size Lid: JN740 (4-1/4 in height), JN741 (5-1/2 in height), JN742 (6 in height), JN744 (8 in height); Full size Lid: JN440 (4-1/4 in height), JN441 (5-1/2 in height), JN442 (6 in height), JN444 (8 in height), JN446 (10-1/2 in height).
Table 2: Steam and IUSS Cycle Compatible Accessories
Stainless Steel baskets, basket lids, and dividers — Yes. Instrument Organization System (Silicone and Stainless Steel racks, brackets, holders, and clamps) — Yes. Silicone mats — Yes. Stainless Steel racks, trays, holders, clamps, brackets, and platforms — Yes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172850: SterilContainer with PrimeLine Pro Lid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172850
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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