# Sumitomo Bakelite Co., Ltd.

- Location (FDA's records): Shinagawa-Ku, JP
- FDA decisions: 4 (2016–2019): 4 510(k) clearances
- Product codes: KNS (2), FDS (1), FED (1)
- 510(k) review time since 2016: median 234 days, against 80 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- United States Endoscopy Group, Inc.: 1 (https://510kreport.com/company/united-states-endoscopy-group)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Firms that cite its devices most
- Sb-Kawasumi Laboratories, Inc.: 1 (https://510kreport.com/company/sb-kawasumi-laboratories)

## Its most-cited devices
- K190621: SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long (2019), cited by 1

## Recent decisions
- K182520: Flexible Overtube (May 15, 2019)
- K190621: SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long (Apr 23, 2019)
- K173004: SB Soft Hood - Straight type, SB Soft Hood - Undercut type (May 8, 2018)
- K152771: SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long (Jun 17, 2016)

Source page: https://510kreport.com/company/sumitomo-bakelite