FDA product code · General Hospital
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Product code KCT covers Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II device regulated under 21 CFR 880.6850. FDA has cleared 280 devices in this code, 6 of them in the last 12 months. Median review time across the 280 most recent decisions is 150 days. openFDA lists 38 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.6850
- Review panel
- General Hospital
- Clearances
- 280
What is happening in KCT right now?
KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories) has two findings, most consequential first. 3 first-time filers in the last 12 months, including MASTEL SURGICAL INC. and DePuy Mitek, Inc (K253187, K253791, K251756). The code is crowded, scoring 85 of 100 — 148 companies hold a clearance here and 6 arrived in the last 12 months (KCT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253187, K253791, K251756 |
| Crowding | Context | KCT:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KCT?
FDA has cleared 280 devices under product code KCT since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG | |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. |
How long does FDA review take for KCT?
The median FDA review time for KCT is 150 days, measured across the 280 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KCT?
openFDA lists 38 recall records against product code KCT. A recall record covers one firm's corrective action and may span many device lots.
Z-2033-2025Open, ClassifiedJewel Precision Sheet Metal & Machining Co, Inc.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Z-2026-2025Open, ClassifiedJewel Precision Sheet Metal & Machining Co, Inc.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Z-2172-2025Open, ClassifiedImplant Direct Sybron Manufacturing, LLC
The Drill stop kit contains incorrect components.
Z-1991-2023Open, ClassifiedKarl Storz Endoscopy
Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Z-1981-2023Open, ClassifiedKarl Storz Endoscopy
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
Showing the 5 most recently initiated of 38. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KCT?
MAUDE holds 79 adverse-event reports naming product code KCT, 19 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KCT unusual?
KCT does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history |
25 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered KCT in the last year?
3 companies filed in KCT for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| MASTEL SURGICAL INC. | K253187 | |
| DePuy Mitek, Inc. | K253791 | |
| Paragon Implant Mfg., LLC | K251756 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KCT?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KCT?
Across the 280 most recent decisions, these applicants filed most often in KCT.
| Applicant | Recent clearances |
|---|---|
| Aesculap, Inc. | 12 |
| STERIS Corporation | 11 |
| Summit Medical, Inc. | 8 |
| Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 7 |
| Intuitive Surgical, Inc. | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in KCT file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Aesculap, Inc. | 13 | 2 |
| Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 10 | 2 |
| Intuitive Surgical, Inc. | 7 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KCT
Get an email the morning anything changes in KCT — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.