510(k) Report

510(k) · Cleared

Recalled · 2003

Barrier Hip Pack W/ Fabric 450

K780282510(k) TraditionalCleared Feb 28, 19787-day reviewRecalls 1

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

Surgikos, Inc.

Cleared on Feb 28, 1978 after a 7-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Feb 28, 1978
Review
7 days
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared19801990200020102020
  1. This deviceK780282 Barrier Hip Pack W/ Fabric 450Surgikos, Inc. · 1978
  2. Descendant · cites it directly · 0 of its ownK051625 Barrier Surgical DrapesMolnlycke Health Care, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K051625Barrier Surgical DrapesMolnlycke Health Care, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K780282Barrier Hip Pack W/ Fabric 450Surgikos, Inc.1978—
+1K051625Barrier Surgical DrapesMolnlycke Health Care, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K780282, 1978–2005Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051625Barrier Surgical DrapesMolnlycke Health Care, Inc.20050

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 14, 2003Not classifiedZ-1137-03Otherpouch may tear which could result in contamination of sterile field

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051625 (Molnlycke Health Care, Inc., 2005) has gone furthest, with 0 descendants of its own.

More from Surgikos, Inc.

56 FDA decisions under this applicant name. See the company

  • K875107Health Care Eye ProtectionSurgikos, Inc. · 1988
  • K874653Sterile Surgical Scrub BrushSurgikos, Inc. · 1987
  • K861441Neutralon Surgical GlovesSurgikos, Inc. · 1986
  • K852870Barrier Surgical GownSurgikos, Inc. · 1985
  • K822535Cidex*Dialyzer Disinfecting SolutionSurgikos, Inc. · 1982

https://510kreport.com/device/K780282 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780282: Barrier Hip Pack W/ Fabric 450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780282

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