510(k) Report

510(k) · Cleared

Cleared

Sta-Put

K872358510(k) TraditionalCleared Aug 6, 198749-day reviewClass I21 CFR 880.2400

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

Design Technologies, Inc. · KMI Monitor, Bed Patient

Cleared on Aug 6, 1987 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 6, 1987
Review
49 days
Class
Class I
Product code
KMI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K872358Source: 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 KMI? 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 KMI devices

KMI Monitor, Bed Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMI

1in 2014

2009: 12010: 12013: 22014: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMI

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

Recalls per year · KMI

1in 2012

2007: 12008: 12009: 72010: 52011: 22012: 1
2007high 7 (2009) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KMI

83in 2025

2007: 202008: 762009: 5102010: 3292011: 3792012: 4212013: 4002014: 3582015: 342016: 242017: 302018: 282019: 142020: 172021: 142022: 212023: 352024: 692025: 83
2007high 510 (2009) · low 14 (2019)2025

MAUDE reports naming product code KMI, 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—120
20080—176
20091—7510
20101—5329
20110—2379
20120—1421
20132—0400
20141—0358
20150—034
20160—024
20170—030
20180—028
20190—014
20200—017
20210—014
20220—021
20230—035
20240—069
20250—083
20260—0—

More from Design Technologies, Inc.

4 FDA decisions under this applicant name. See the company

  • K872038Neb-U-VentDesign Technologies, Inc. · 1987
  • K871262Modified Noflo IDesign Technologies, Inc. · 1987
  • K863613NO-Flo IDesign Technologies, Inc. · 1986

Recent decisions in KMI

The KMI category page

  • K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
  • K131585Intel-GE Care Innovations QuietcareIntel-Ge Care Innovations, LLC · 2013
  • K130752Dynasense SystemCentauri Medical, Inc. · 2013
  • K101109VivatrakWireless Medcare, LLC · 2010
  • K090138Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009

https://510kreport.com/device/K872358 · printed Nov 5, 2026

Cite this page

510(k) Report. “K872358: Sta-Put.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K872358

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