510(k) Report

510(k) · Cleared

Cleared

Tamper Hamper

K863872510(k) TraditionalCleared Feb 10, 1987130-day reviewClass U

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. · LPZ Container, Frozen Donor Tissue Storage

Cleared on Feb 10, 1987 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 10, 1987
Review
130 days
Class
Class U
Product code
LPZ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K863872Source: 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.

Planning a device in LPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, 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 LPZ devices

LPZ Container, Frozen Donor Tissue Storage: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPZ

FDA has decided no LPZ device since 2007.

Median 510(k) review, days · LPZ

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

Recalls per year · LPZ

No recall names LPZ since 2007.

Adverse event reports per year · LPZ

1in 2025

2011: 52012: 22016: 162017: 242018: 232019: 72020: 162021: 12024: 12025: 1
2007high 24 (2017) · low 0 (2007)2025

MAUDE reports naming product code LPZ, not matched to any one device; reports are not rates.

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—05
20120—02
20130—00
20140—00
20150—00
20160—016
20170—024
20180—023
20190—07
20200—016
20210—01
20220—00
20230—00
20240—01
20250—01
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
  • K923099X-Ray DrapesHydro-Med Products, Inc. · 1992

Recent decisions in LPZ

The LPZ category page

  • K021702Cryobag, Model CBOrigen Biomedical, Inc. · 2002
  • K915471CryobagJanus Biomedical, Inc. · 1994
  • K861761Accessus Dry Storage Package Sterile Comp StorageTravenol Laboratories, S.A. · 1986
  • K860511Ampu-PakAmmerman Medical Enterprises, Inc. · 1986
  • K853663Accessus Cryopreservation PKG. Sterile Tissue StorTravenol Laboratories, S.A. · 1986

https://510kreport.com/device/K863872 · printed Nov 4, 2026

Cite this page

510(k) Report. “K863872: Tamper Hamper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K863872

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