510(k) Report

FDA applicant

Senorx, Inc.

Aliso Viejo, CA30 decisions2000–202310 recalls

FDA records 30 decisions for Senorx, Inc. (Aliso Viejo, CA) from 2000 to 2023: 30 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and NEU (Marker, Radiographic, Implantable). Since 2016 its 510(k)s took a median of 27 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 19 of them its own earlier devices. 10 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2023

2007: 22008: 62009: 22013: 12016: 12021: 12023: 1
2007high 6 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

4in 2020

2019: 62020: 4
2007high 6 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Senorx, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Senorx, 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?

  • KNWInstrument, Biopsy9decisions
  • NEUMarker, Radiographic, Implantable7decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • JAQSystem, Applicator, Radionuclide, Remote-Controlled5decisions
  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • GDWStaple, Implantable1decision

Also: FZP (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 27 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 44 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 32 times; 19 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.

  • K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 20073cite it
  • K093512Encor Breast Biopsy SystemSenorx, Inc. · 20093cite it
  • K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc. · 20012cite it
  • K040842Senorx Biopsy Device IISenorx, Inc. · 20042cite it
  • K000060Gel Mark Biopsy Site Marker, Models MKOOO1, MK0004, MK0007Senorx, Inc. · 20002cite it
  • K051158Encor 7 GaugeSenorx, Inc. · 20052cite it

What has FDA decided for it lately?

  • K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast…Senorx, Inc. · 2023
  • K210654EnCor Breast Biopsy Probe with Rinse TubeSenorx, Inc. · 2021
  • K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. · 2016
  • K131654Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerSenorx, Inc. · 2013
  • K093512Encor Breast Biopsy SystemSenorx, Inc. · 2009
  • K092323Contura Cavity Maintenance CatheterSenorx, Inc. · 2009
  • K082264Contura Lumen MarkerSenorx, Inc. · 2008
  • K081085Starchmark Biopsy Site Marker, Model Stmkec-10GSS, Stmkec-10GTR, Stmkmt-11GSSenorx, Inc. · 2008

All 30 as Senorx, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K040842Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged…Jan 3, 2020Class II
  • K040842Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged…Jan 3, 2020Class II
  • K040842Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually…Jan 3, 2020Class II
  • K040842Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged…Jan 3, 2020Class II
  • K051158EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…May 2, 2019Class II
  • K051158EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…May 2, 2019Class II