510(k) Report

510(k) · Cleared

Cleared

Blood Line Comp. Neg. Press. Pillow

K772355510(k) TraditionalCleared Jan 26, 197830-day reviewClass II21 CFR 876.5820

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

Cordis Corp. · FIW Alarm, Pillow Pressure

Cleared on Jan 26, 1978 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 26, 1978
Review
30 days
Class
Class II
Product code
FIW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K772355Source: 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 FIW? 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 FIW devices

FIW Alarm, Pillow Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIW

FDA has decided no FIW device since 2007.

Median 510(k) review, days · FIW

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

Recalls per year · FIW

No recall names FIW since 2007.

Adverse event reports per year · FIW

No MAUDE report names FIW 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 Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

https://510kreport.com/device/K772355 · printed Nov 6, 2026

Cite this page

510(k) Report. “K772355: Blood Line Comp. Neg. Press. Pillow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K772355

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