510(k) Report

510(k) · Cleared

Cleared

X-Ray Drapes

K923099510(k) TraditionalCleared Oct 15, 1992112-day reviewClass I21 CFR 892.6500

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

Hydro-Med Products, Inc. · IWQ Curtain, Protective, Radiographic

Cleared on Oct 15, 1992 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Oct 15, 1992
Review
112 days
Class
Class I
Product code
IWQ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K923099Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All IWQ devices

IWQ Curtain, Protective, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWQ

FDA has decided no IWQ device since 2007.

Median 510(k) review, days · IWQ

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

Recalls per year · IWQ

No recall names IWQ since 2007.

Adverse event reports per year · IWQ

No MAUDE report names IWQ 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—

More from Hydro-Med Products, Inc.

13 FDA decisions under this applicant name. See the company

  • K944198Surgical Microscope DrapeHydro-Med Products, Inc. · 1994
  • K940151Ultrasound Probe DrapeHydro-Med Products, Inc. · 19941 recall
  • K934630Universal Video/Laser Arm DrapeHydro-Med Products, Inc. · 1994
  • K940152Camera Cover with Tear TipHydro-Med Products, Inc. · 1994
  • K863872Tamper HamperHydro-Med Products, Inc. · 1987

Recent decisions in IWQ

The IWQ category page

  • K945238Mavig Lower Body Protection Systems, Assembly Models 6265, 6266, 6267, 6268, 6269/0, 629/1, and 6269/2F. Walter Hanel GmbH · 1994
  • K873038Techton Protective PadTechton, Inc. · 1989

https://510kreport.com/device/K923099 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923099: X-Ray Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923099

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026