510(k) Report

FDA applicant

Bio Compression Systems, Inc.

Moonachie, NJ16 decisions1996–20260 recalls

FDA records 16 decisions for Bio Compression Systems, Inc. (Moonachie, NJ) from 1996 to 2026: 16 510(k) clearances. Most are in product codes JOW (Sleeve, Limb, Compressible) and IRP (Massager, Powered Inflatable Tube). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 13 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2007: 12013: 32014: 12015: 12017: 12018: 12021: 12022: 12025: 12026 (partial year): 1
2007high 3 (2013) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bio Compression 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?

  • JOWSleeve, Limb, Compressible12decisions
  • IRPMassager, Powered Inflatable Tube3decisions
  • ILOPack, Hot Or Cold, Water Circulating1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 13 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.

  • K043423Model SC-3008 Sequential CirculatorBio Compression Systems, Inc. · 20059cite it
  • K072666Bioarterial Plus, Arterial Blood Flow Enhancement SystemBio Compression Systems, Inc. · 20074cite it
  • K142640Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL…Bio Compression Systems, Inc. · 20143cite it
  • K210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLBio Compression Systems, Inc. · 20212cite it
  • K061857Model Multi-Flo IC-1545-KT/-F Intermittent CirculatorBio Compression Systems, Inc. · 20062cite it
  • K1221122004-OC Massage System, 2008-OC Massage SystemBio Compression Systems, Inc. · 20132cite it

What has FDA decided for it lately?

  • K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
  • K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc. · 2025
  • K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLBio Compression Systems, Inc. · 2022
  • K210417Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DLBio Compression Systems, Inc. · 2021
  • K180248VascuEase IC-1200-WHBio Compression Systems, Inc. · 2018
  • K171793Sequential Circulator SC-2004FC-OCBio Compression Systems, Inc. · 2017
  • K150953Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OCBio Compression Systems, Inc. · 2015
  • K142640Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL…Bio Compression Systems, Inc. · 2014

All 16 as Bio Compression Systems, Inc. →