510(k) Report

FDA applicant

Picis, Inc.

Philedelphia, PA2 decisions1995–20120 recalls

FDA records 2 decisions for Picis, Inc. (Philedelphia, PA) from 1995 to 2012: 2 510(k) clearances. Most are in product codes NDC (Calculator, Drug Dose) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Picis”.

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

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

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

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Picis, 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?

  • NDCCalculator, Drug Dose1decision
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K121542Picis Weight Based Dose ConverterPicis, Inc. · 20121cites it

What has FDA decided for it lately?

  • K121542Picis Weight Based Dose ConverterPicis, Inc. · 2012
  • K950536Picis Chart+Picis · 1995

The one decision as Picis, Inc. →The one decision as Picis →