510(k) Report

FDA applicant

Pharmaceutical Innovations, Inc.

Newark, NJ5 decisions1996–20180 recalls

FDA records 5 decisions for Pharmaceutical Innovations, Inc. (Newark, NJ) from 1996 to 2018: 5 510(k) clearances. Most are in product codes MUI (Media, Coupling, Ultrasound) and KMJ (Lubricant, Patient). Since 2016 its 510(k)s took a median of 435 days from receipt to decision, against 434 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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 Pharmaceutical Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2018

2018: 4
2007high 4 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pharmaceutical Innovations, Inc.’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?

  • MUIMedia, Coupling, Ultrasound4decisions
  • KMJLubricant, Patient1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 435 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 434 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K961222Evron GelPharmaceutical Innovations, Inc. · 19961cites it
  • K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 20181cites it

What has FDA decided for it lately?

  • K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc. · 2018
  • K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. · 2018
  • K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc. · 2018
  • K163023Other-Sonic Transmission GelPharmaceutical Innovations, Inc. · 2018
  • K961222Evron GelPharmaceutical Innovations, Inc. · 1996

All 5 as Pharmaceutical Innovations, Inc. →

Other applicant names beginning “Pharmaceutical”

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

Pharmaceutical Development Systems 1Pharmaceutical Infusion Technologies, Inc. 1