510(k) Report

FDA applicant

Zap Surgical Systems, Inc.

San Carlos, CA4 decisions2017–20252 recalls

FDA records 4 decisions for Zap Surgical Systems, Inc. (San Carlos, CA) from 2017 to 2025: 4 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 76 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Zap Surgical Systems”.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Zap Surgical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12019: 12021: 12025: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 12025: 1
2017high 1 (2022) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Zap Surgical Systems, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 76 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211663Zap-X Radiosurgical SystemZap Surgical Systems, Inc. · 20211cites it
  • K183698Zap-X Radiosurgery SystemZap Surgical Systems · 20191cites it
  • K171804Zap-X Radiosurgery SystemZap Surgical Systems · 20171cites it

What has FDA decided for it lately?

  • K250392ZAP-X Radiosurgery System (ZAP-X)Zap Surgical Systems, Inc. · 2025
  • K211663Zap-X Radiosurgical SystemZap Surgical Systems, Inc. · 20212 recalls
  • K183698Zap-X Radiosurgery SystemZap Surgical Systems · 2019
  • K171804Zap-X Radiosurgery SystemZap Surgical Systems · 2017

All 2 as Zap Surgical Systems, Inc. →All 2 as Zap Surgical Systems →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K211663ZAP-X Radiosurgery System, Model: 300150Jul 25, 2025Class II
  • K211663ZAP-X Radiosurgery SystemJul 5, 2022Class II