510(k) Report

510(k) · Cleared

Cleared

Cell-Culture Shaker

K881466510(k) TraditionalCleared Apr 18, 198812-day reviewClass I21 CFR 864.2240

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

Cryodyne Technologies, Inc. · KJB Apparatus, Roller

Cleared on Apr 18, 1988 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 18, 1988
Review
12 days
Class
Class I
Product code
KJB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K881466Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 KJB? 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
Get a 510(k) Report

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 KJB devices

KJB Apparatus, Roller: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KJB

FDA has decided no KJB device since 2007.

Median 510(k) review, days · KJB

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

Recalls per year · KJB

No recall names KJB since 2007.

Adverse event reports per year · KJB

No MAUDE report names KJB 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 Cryodyne Technologies, Inc.

6 FDA decisions under this applicant name. See the company

  • K926464L.C.S.3000Cryodyne Technologies, Inc. · 1993
  • K932520Calibration GasCryodyne Technologies, Inc. · 1993
  • K881465Cryobiological FreezerCryodyne Technologies, Inc. · 1988
  • K881467Microscope Stage HeaterCryodyne Technologies, Inc. · 1988
  • K860738CTC 30, 40, 1 Liquid Oxygen LitersCryodyne Technologies, Inc. · 1986

Recent decisions in KJB

The KJB category page

  • K872076Corning Disposable Roller BottlesCorning Medical & Scientific · 1987
  • K852506Bioglas Microcarrier BeadSolohill Engineering, Inc. · 1985

https://510kreport.com/device/K881466 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881466: Cell-Culture Shaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881466

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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