510(k) Report

510(k) · Cleared

Cleared

Custom Instrument Drape

K843890510(k) TraditionalCleared Oct 26, 198424-day reviewClass II21 CFR 878.4370

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

Lifestream Int'L, Inc. · HMW Drape, Microscope, Ophthalmic

Cleared on Oct 26, 1984 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 26, 1984
Review
24 days
Class
Class II
Product code
HMW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K843890Source: 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 HMW? 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 HMW devices

HMW Drape, Microscope, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HMW

FDA has decided no HMW device since 2007.

Median 510(k) review, days · HMW

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

Recalls per year · HMW

No recall names HMW since 2007.

Adverse event reports per year · HMW

No MAUDE report names HMW 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 Lifestream Int'L, Inc.

23 FDA decisions under this applicant name. See the company

  • K964571Vision Cardioplegia Delivery SystemLifestream Int'L, Inc. · 1997
  • K962354Diomed 15, 30, 60 Surgical Diode LaserLifestream Int'L, Inc. · 1996
  • K920178Cardiotomy Reservoir W/20 Micron FiliterLifestream Int'L, Inc. · 1993
  • K920618Autotransfusion Suction SetLifestream Int'L, Inc. · 1993
  • K913181Autologous Blood Processing SystemLifestream Int'L, Inc. · 1992

Recent decisions in HMW

The HMW category page

  • K911040Invotec Microscope DrapeInvotec International, Inc. · 1991
  • K902763Sterile Instrument DrapeNorth American Sterilization & Packaging Co. · 1990
  • K902851Microscope DrapeMedical Technique Instruments, Inc. · 1990

https://510kreport.com/device/K843890 · printed Nov 4, 2026

Cite this page

510(k) Report. “K843890: Custom Instrument Drape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K843890

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