510(k) Report

FDA applicant

Porter Instrument Co., Inc.

Hatfield, PA6 decisions1980–20061 recall

FDA records 6 decisions for Porter Instrument Co., Inc. (Hatfield, PA) from 1980 to 2006: 6 510(k) clearances. Most are in product codes CBN (Apparatus, Gas-Scavenging) and FLE (Sterilizer, Steam). Its devices cite 5 predicates, 2 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Porter Instrument Co., Inc. since 2007.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Porter Instrument Co., 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?

  • CBNApparatus, Gas-Scavenging2decisions
  • FLESterilizer, Steam2decisions
  • CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1decision
  • BSZGas-Machine, Anesthesia1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 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.

  • K923781MXR-2000 FlowmeterPorter Instrument Co., Inc. · 19931cites it
  • K802067Clean-Air Pollution Reduction SystemPorter Instrument Co., Inc. · 19801cites it

What has FDA decided for it lately?

  • K062155Digital MXR-D FlowmeterPorter Instrument Co., Inc. · 20061 recall
  • K981754Automatic Vacuum Switch (Avs) Model Number Avs 5000Porter Instrument Co., Inc. · 1998
  • K924596Ses-2012 Automatic Steam SterilizerPorter Instrument Co., Inc. · 1994
  • K923781MXR-2000 FlowmeterPorter Instrument Co., Inc. · 19931 recall
  • K895638Steam Sterilizer (Autoclave), DentalPorter Instrument Co., Inc. · 1990
  • K802067Clean-Air Pollution Reduction SystemPorter Instrument Co., Inc. · 1980

All 6 as Porter Instrument Co., Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062155Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a…Aug 26, 2008