510(k) Report

510(k) · Cleared

Cleared

Cryobag, Model CB

K021702510(k) TraditionalCleared Aug 6, 200275-day reviewClass U

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

Origen Biomedical, Inc. · LPZ Container, Frozen Donor Tissue Storage

Cleared on Aug 6, 2002 as substantially equivalent to K915471 (Janus Biomedical, Inc., 1994) after a 75-day review. Its family tree reaches back 1 generation to 1994.

Decided
Aug 6, 2002
Review
75 days
Class
Class U
Product code
LPZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K915471 (1994). No later device cites it as a predicate yet.

K915471 · Cryobag · Janus Biomedical, Inc. · 199419901992199419961998200020022004
K915471 · Cryobag · Janus Biomedical, Inc. · 19940
  1. Root · 1 generation backK915471 CryobagJanus Biomedical, Inc. · 1994
  2. This deviceK021702 Cryobag, Model CBOrigen Biomedical, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915471CryobagJanus Biomedical, Inc.1994—
0 (this device)K021702Cryobag, Model CBOrigen Biomedical, Inc.2002—
FIG. 1 — Lineage of K021702, 1994–2002Source: FDA 510(k) summaries, read by 510(k) Report · 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K915471Cryobag
Summary page 1
…21 CFR 880 OriGen Tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues. These are the same devices originally approved under K915471. This 510(k) application is being submitted to document the change of sterilization method from Ethylene Oxide to radiation. Phys…
Janus Biomedical, Inc.1994—

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.

What does this lineage say?

  • Its one ancestor has no 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—

What is it indicated for?

The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.

Indications for use as stated in the FDA summary.

More from Origen Biomedical, Inc.

4 FDA decisions under this applicant name. See the company

  • K113869Origen Reinforced Dual Lumen CatheterOrigen Biomedical, Inc. · 20129 Class I recalls
  • K003288Origen Dual Lumen CatheterOrigen Biomedical, Inc. · 2001
  • K003145Origen Bladder HolderOrigen Biomedical, Inc. · 2001

Recent decisions in LPZ

The LPZ category page

  • K915471CryobagJanus Biomedical, Inc. · 1994
  • K863872Tamper HamperHydro-Med Products, Inc. · 1987
  • 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/K021702 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021702: Cryobag, Model CB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021702

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026