510(k) Report

FDA product code · Orthopedic

Belt, Pelvic, Traction

HSQClass I21 CFR 888.5890510(k) exempt1 decision since 19760 recalls

FDA lists HSQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 888.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1976. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of HSQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · HSQ

FDA has decided no HSQ device since 2007.

Median 510(k) review, days · HSQ

Too few HSQ 510(k)s in any year since 2007 to give a median.

Recalls per year · HSQ

No recall names HSQ since 2007.

Adverse event reports per year · HSQ

No MAUDE report names HSQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — HSQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in HSQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in HSQ lately?

  • K761036Wilson Spinal FrameOrthopedic Equipment Co., Inc. · 1976

The one HSQ decision →

Related product codes

Other codes under 21 CFR 888.5890.

HSS Halter, Head, TractionHSP Splint, TractionHSR Unit, Traction, Hip, Non-Powered…KQZ Component, Traction, Non-Invasive