Boston Scientific Corp: FDA clearances and approvals

Boston Scientific Corp has 730 FDA 510(k) clearances (first 1988, latest 2026), plus 75 PMA and 2 De Novo decisions, across 175 product codes in 13 review panels. Median 510(k) review time: 78 days. Since 2017 its median was 77 days, against 110 days for all cleared 510(k)s in the same product codes. openFDA lists 1,255 product recalls by a recalling firm named Boston Scientific Corp. It is the industry lead sponsor of 403 device clinical trials on ClinicalTrials.gov. It files with the SEC as BOSTON SCIENTIFIC CORP (BSX).

510(k) clearances per year

Review time against the same product codes

Since 2017, Boston Scientific Corp's cleared 510(k)s took a median 77 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.

Top product codes

Plus 165 more product codes.

Review panels

• Cardiovascular (372)
• Gastroenterology and Urology (292)
• General and Plastic Surgery (48)
• Radiology (26)
• Ear, Nose and Throat (14)
• Neurology (14)
• Obstetrics and Gynecology (14)
• General Hospital (13)
• Anesthesiology (8)
• Immunology (2)
• Orthopedic (2)
• Physical Medicine (1)
• Clinical Toxicology (1)

Most recent Boston Scientific Corp 510(k) clearances

720 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

1,255 product recalls in 310 recall events; 355 initiated in the last five years. Most recent: 2026-08-24.

Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.

Device clinical trials

Boston Scientific Corp is the industry lead sponsor of 403 device studies on ClinicalTrials.gov (59 active or recruiting). Most recent:

• NCT07035431: Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area (Recruiting, started 2026-05)
• NCT07015424: Randomized Study on Transoral Outlet Reduction and Lifestyle Changes for Weight Regain After Gastric Bypass (Recruiting, started 2026-04-14)
• NCT07062094: Safety and Effectiveness of Orbera365™ Intragastric Balloon System (Recruiting, started 2026-04-07)
• NCT07444320: Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System (Recruiting, started 2026-02-12)
• NCT07377487: TheraSphere Japan Pre-Market Study (Recruiting, started 2026-01-22)

SEC filings

BOSTON SCIENTIFIC CORP (BSX): EDGAR filings, CIK 885725. Matched by exact company name.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of Boston Scientific Corp's product codes (a text match, not an official crosswalk):

• C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
• C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via OOB)
• L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via EZW)
• C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via OOB)
• C9603 — Percutaneous transluminal coronary atherectomy, with drug-eluting intracoronary stent, with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) (via OOB)

Frequently asked questions

How many FDA 510(k) clearances does Boston Scientific Corp have?

Boston Scientific Corp has 730 FDA 510(k) clearances (first 1988, latest 2026), plus 75 PMA and 2 De Novo decisions, across 175 product codes in 13 review panels.

How long does FDA take to clear Boston Scientific Corp's 510(k)s?

The median time from FDA receipt to decision across Boston Scientific Corp's cleared 510(k)s is 78 days. Since 2017: 77 days, versus 110 days for all cleared 510(k)s in the same product codes.

What devices does Boston Scientific Corp make?

Its most frequent FDA product codes are FGE (Stents, Drains And Dilators For The Biliary Ducts, 56); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 52); DQX (Wire, Guide, Catheter, 34).

Has Boston Scientific Corp had device recalls?

openFDA lists 1,255 product recalls in 310 recall events by a recalling firm whose name matches Boston Scientific Corp; the most recent began 2026-08-24. Recall firm names are matched by name, so related entities filing under other names are not included.

Next steps

• See all 730 Boston Scientific Corp clearances with predicates and recalls
• Run predicate analysis for product code FGE, Boston Scientific Corp's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.

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