510(k) Report

510(k) · Cleared

Cleared

Labor-Delivery Stretch/Bed

K861030510(k) TraditionalCleared Apr 23, 198636-day reviewClass II21 CFR 884.4900

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

Adel Medical, Ltd. · KNC Table, Obstetric (And Accessories)

Cleared on Apr 23, 1986 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 23, 1986
Review
36 days
Class
Class II
Product code
KNC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K861030Source: 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 KNC? 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 KNC devices

KNC Table, Obstetric (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNC

FDA has decided no KNC device since 2007.

Median 510(k) review, days · KNC

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

Recalls per year · KNC

4in 2007

2007: 4
2007high 4 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KNC

113in 2025

2007: 12008: 12012: 42013: 12014: 112015: 152017: 22018: 372019: 602020: 442021: 252022: 252023: 452024: 712025: 113
2007high 113 (2025) · low 0 (2009)2025

MAUDE reports naming product code KNC, 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—41
20080—01
20090—00
20100—00
20110—00
20120—04
20130—01
20140—011
20150—015
20160—00
20170—02
20180—037
20190—060
20200—044
20210—025
20220—025
20230—045
20240—071
20250—0113
20260—0—

More from Adel Medical, Ltd.

8 FDA decisions under this applicant name. See the company

  • K890476Adel - Model 986 Infant WarmerAdel Medical, Ltd. · 1989
  • K874610Adel Model 2100 Birthing BedAdel Medical, Ltd. · 1988
  • K871475Sololift - Patient Transfer StretcherAdel Medical, Ltd. · 1987
  • K860020Minor Surgery Light Model 2112Adel Medical, Ltd. · 1986
  • K833321Labor/Delivery/Recovery Bed LDR-600Adel Medical, Ltd. · 1983

Recent decisions in KNC

The KNC category page

  • K001261L720 Examination ChairLuneau Gynecologie SA · 2000
  • K932035Non-Linting Delivery BlanketAmsco Sterile Recoveries, Inc. · 1994
  • K924420Medical Disposable BeddingHill-Rom, Inc. · 1993
  • K914544BD6000 the Optima & BD5000 Birthing BedLic Care, Inc. · 1993
  • K915779Affinity Bed Model 3600 SeriesHill-Rom, Inc. · 199311 recalls

https://510kreport.com/device/K861030 · printed Nov 6, 2026

Cite this page

510(k) Report. “K861030: Labor-Delivery Stretch/Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861030

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