TRACHEOSTOMY CARE KIT (STERILE)— 510(k) K925020
UnknownCustomed, Inc.
FDA 510(k) clearance K925020 for TRACHEOSTOMY CARE KIT (STERILE), Unknown on 1993-07-07. Applicant: Customed, Inc.. Device class: 2.
Clearance details
- Applicant
- Customed, Inc.
- Product code
- Code JOH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5800
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Fajardo, PR, US
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- K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
More clearances from Customed, Inc.
view all- K974647 — FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
- K971920 — GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
- K964011 — SUCTION CATHETER TRAY PRODUCT NO. 900277
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962596 — CUSTOMED BLOOD EXTRACTION KIT
Adverse events under product code JOH
product code JOH- Death
- 42
- Injury
- 1,344
- Malfunction
- 5,608
- Other
- 1
- Total
- 6,995
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K925020
K-number listed on FDA's recall record- Z-1411-2016 — Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Z-2565-2015 — TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925020.
Data sourced from openFDA. This site is unofficial and independent of the FDA.