510(k) Report

510(k) · Cleared

Cleared

Akrotech 4000T Kinetic Turning Low Air Loss System

K962123510(k) TraditionalCleared Jul 18, 199648-day reviewClass II21 CFR 880.5550

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

Lumex, Inc. · FNM Mattress, Air Flotation, Alternating Pressure

Cleared on Jul 18, 1996 as substantially equivalent to K923977 (Lumex, Inc., 1993) after a 48-day review. Its family tree reaches back 1 generation to 1993.

Decided
Jul 18, 1996
Review
48 days
Class
Class II
Product code
FNM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K923977 (1993). No later device cites it as a predicate yet.

K923977 · Akrotech 4000 · Lumex, Inc. · 199319901992199419961998
K923977 · Akrotech 4000 · Lumex, Inc. · 19930
  1. Root · 1 generation backK923977 Akrotech 4000Lumex, Inc. · 1993
  2. This deviceK962123 Akrotech 4000T Kinetic Turning Low Air Loss SystemLumex, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K923977Akrotech 4000Lumex, Inc.1993—
0 (this device)K962123Akrotech 4000T Kinetic Turning Low Air Loss SystemLumex, Inc.1996—
FIG. 1 — Lineage of K962123, 1993–1996Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FNM? 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K923977Akrotech 4000
Summary page 2
…hed under section 514 See attachments This product is similar to the AkroTech 4000 product submitted by Lumex Div. of Lumex, Inc. approved by the FDA reference number K923977. 1/3 510(k) Summary (cont’d) The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System,…
Lumex, Inc.1993—

Also cleared against K923977: 1 other device →

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K923977.

How does its category compare?

All FNM devices

FNM Mattress, Air Flotation, Alternating Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FNM

FDA has decided no FNM device since 2007.

Median 510(k) review, days · FNM

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

Recalls per year · FNM

1in 2025

2008: 42010: 12025: 1
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FNM

128in 2025

2007: 332008: 352009: 332010: 562011: 2912012: 3032013: 2232014: 802015: 802016: 502017: 562018: 1152019: 1012020: 582021: 472022: 752023: 1972024: 2542025: 128
2007high 303 (2012) · low 33 (2007)2025

MAUDE reports naming product code FNM, 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—033
20080—435
20090—033
20100—156
20110—0291
20120—0303
20130—0223
20140—080
20150—080
20160—050
20170—056
20180—0115
20190—0101
20200—058
20210—047
20220—075
20230—0197
20240—0254
20250—1128
20260—0—

Also cleared against K923977

1 other device cites the same predicate.

  • K963674Lumex AirLumex, Inc. · 1997

More from Lumex, Inc.

8 FDA decisions under this applicant name. See the company

  • K963674Lumex AirLumex, Inc. · 1997
  • K953675AltadyneLumex, Inc. · 1995
  • K945175Mechanical Wheelchair 890.3850Lumex, Inc. · 1995
  • K945257577ES (Ergosense)Lumex, Inc. · 1995
  • K944574Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000, Tilt-in-Space, 6000, Mri)Lumex, Inc. · 1994

Recent decisions in FNM

The FNM category page

  • K973169Pressure Guard Site Select (a)Span-America Medical Systems, Inc. · 1998
  • K974319Mighty AirWheelchairs of Kansas · 1998
  • K972022ZAK-2000Cardio Systems, Inc. · 1998
  • K974070Physio/1000Physio Designs, Inc. · 1998
  • K972549SimpulseKinetic Concepts, Inc. · 1997

https://510kreport.com/device/K962123 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962123: Akrotech 4000T Kinetic Turning Low Air Loss System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962123

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026