510(k) Report

510(k) · Decided

Decided

Sterile Design

K934688510(k) TraditionalDecided Mar 16, 1994167-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

Sterile Design, Inc. · LRO General Surgery Tray

Cleared on Mar 16, 1994 after a 167-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 16, 1994
Review
167 days
Class
Class II
Product code
LRO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK934688 Sterile DesignSterile Design, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK041080 Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L. · 2004
  3. Descendant · 2 generations on · 0 of its ownK110724 Surgical Procedure PacksOmnia Spa · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K041080Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L. · 2004 · cites it directly1descendant
  • K110724Surgical Procedure PacksOmnia Spa · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934688Sterile DesignSterile Design, Inc.1994—
+1K041080Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L.2004—
+2K110724Surgical Procedure PacksOmnia Spa2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
FIG. 1 — Lineage of K934688, 1994–2011Source: 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.

Planning a device in LRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LRO device

  1. #1 K212258 Medline Cardiovascular Procedure Kitscore 2.4 · 1 generation · no Class I recall
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? (2)

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

NumberDeviceApplicantDecidedDescendants
K041080Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L.20041

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?

  • Of its descendants, K041080 (D.I.R.R.a. S.R.L., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LRO devices

LRO General Surgery Tray: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRO

1in 2022

2021: 12022: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LRO

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

Recalls per year · LRO

14in 2025

2007: 12009: 22010: 12011: 112012: 42013: 11, 11 Class I2014: 59, 58 Class I2015: 52016: 42017: 292018: 312019: 42020: 32021: 32022: 1922023: 18, 2 Class I2024: 60, 1 Class I2025: 14, 5 Class I2026 (partial year): 75, 16 Class I
2007high 192 (2022) · low 0 (2008)2026

Class I (93 since 2007) Class II/III not classified

Adverse event reports per year · LRO

5,488in 2025

2007: 82008: 82009: 52010: 232011: 172012: 642013: 252014: 592015: 6282016: 8052017: 5232018: 3842019: 4062020: 7672021: 9202022: 1,1342023: 1,9132024: 3,0312025: 5,488
2007high 5,488 (2025) · low 5 (2009)2025

MAUDE reports naming product code LRO, 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—18
20080—08
20090—25
20100—123
20110—1117
20120—464
20130—11 (11)25
20140—59 (58)59
20150—5628
20160—4805
20170—29523
20180—31384
20190—4406
20200—3767
20211—3920
20221—1921,134
20230—18 (2)1,913
20240—60 (1)3,031
20250—14 (5)5,488
20260—75 (16)—

More from Sterile Design, Inc.

10 FDA decisions under this applicant name. See the company

  • K841960Cardio Metrics Invasive Pressure MonitSterile Design, Inc. · 1985
  • K842356Custom Sterile Procedure KitsSterile Design, Inc. · 1985
  • K841959Cardio Metric Custom Perfusion TubingSterile Design, Inc. · 19841 recall
  • K842351Sterile Design-Custom Sterile IV KitSterile Design, Inc. · 1984
  • K841958Cardio Metrics Cardiotomy ReservoirSterile Design, Inc. · 1984

Recent decisions in LRO

The LRO category page

  • K213481Medline General Surgery TrayMedline Industries, Inc. · 202211 Class I recalls
  • K212258Medline Cardiovascular Procedure KitMedline Industries, Inc. · 2021
  • K041080Surgical Drape Kit - D.I.R.R.a. SRLD.I.R.R.a. S.R.L. · 2004
  • K030721Quick-Tap Paracentesis Tray, Kit & NeedleBallard Medical Products · 2003
  • K023276Amsino Tracheostomy Care TrayAmsino International, Inc. · 2002

https://510kreport.com/device/K934688 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934688: Sterile Design.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934688

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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