# K902921: Rayon Neurological Sponge

- Pathway: 510(k) (Traditional)
- Applicant: American Silk Sutures, Inc.
- Decided: Sep 18, 1990 after 77 days
- Product code: HBA (Neurosurgical Paddie)
- Device class: 2
- Regulation: 21 CFR 882.4700
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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.

## Most influential descendants
- K121822: Delicot (2012), 0 descendants of its own

## Recalls of this device
- Mar 31, 2016 · Class II · Z-1795-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1770-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1771-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1798-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1796-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1772-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1794-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1768-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1767-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1774-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1765-2016: Product packaging defective compromising sterility
- Mar 31, 2016 · Class II · Z-1797-2016: Product packaging defective compromising sterility

Source page: https://510kreport.com/device/K902921
Methodology: https://510kreport.com/methodology