# K903340: Sterile Urethral Catheter Procedure Kits

- Pathway: 510(k) (Traditional)
- Applicant: Superior Healthcare Group, Inc.
- Decided: Oct 4, 1990 after 71 days
- Product code: FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit))
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 4, 2023 · Class I · Z-1045-2024: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
- Nov 1, 2022 · Class II · Z-0357-2023: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may in
- Nov 1, 2022 · Class II · Z-0358-2023: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may in
- Nov 1, 2022 · Class II · Z-0361-2023: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may in
- Nov 1, 2022 · Class II · Z-0356-2023: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may in
- Nov 1, 2022 · Class II · Z-0359-2023: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may in
- Nov 1, 2022 · Class II · Z-0360-2023: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may in

Source page: https://510kreport.com/device/K903340
Methodology: https://510kreport.com/methodology