510(k) Report

FDA applicant

Sumitomo Bakelite Co., Ltd.

Shinagawa-Ku, JP4 decisions2016–20192 recalls

FDA records 4 decisions for Sumitomo Bakelite Co., Ltd. (Shinagawa-Ku, JP) from 2016 to 2019: 4 510(k) clearances. Most are in product codes KNS (Unit, Electrosurgical, Endoscopic (With Or…) and FDS (Gastroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 234 days from receipt to decision, against 80 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Sumitomo Bakelite Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2016: 12018: 12019: 2
2016high 2 (2019) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

2in 2016

2016: 2
2016high 2 (2016) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Sumitomo Bakelite Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sumitomo Bakelite Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2decisions
  • FDSGastroscope And Accessories, Flexible/Rigid1decision
  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 234 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 80 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongSumitomo Bakelite Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K182520Flexible OvertubeSumitomo Bakelite Co., Ltd. · 2019
  • K190621SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongSumitomo Bakelite Co., Ltd. · 2019
  • K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd. · 2018
  • K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd. · 20162 recalls

All 4 as Sumitomo Bakelite Co., Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K152771SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm.…Sep 9, 2016Class II
  • K152771SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD…Sep 9, 2016Class II

Other applicant names beginning “Sumitomo”

FDA records each applicant name separately; these may or may not be the same firm.

Sumitomo Electric Industries, Inc. 2Sumitomo Heavy Industries, Ltd. 2