510(k) Report

510(k) · Cleared

Cleared

Supercair

K890523510(k) TraditionalCleared Feb 10, 19898-day reviewClass II21 CFR 890.5160

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

Ssi Medical Services, Inc. · INX Bed, Air Fluidized

Cleared on Feb 10, 1989 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 10, 1989
Review
8 days
Class
Class II
Product code
INX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890523Source: 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 INX? 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 INX devices

INX Bed, Air Fluidized: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · INX

FDA has decided no INX device since 2007.

Median 510(k) review, days · INX

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

Recalls per year · INX

2in 2012

2009: 22012: 2
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · INX

170in 2025

2007: 92008: 192009: 292010: 142011: 232012: 122013: 3522014: 2822015: 512016: 102017: 282018: 222019: 152020: 32021: 22022: 182023: 602024: 802025: 170
2007high 352 (2013) · low 2 (2021)2025

MAUDE reports naming product code INX, 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—09
20080—019
20090—229
20100—014
20110—023
20120—212
20130—0352
20140—0282
20150—051
20160—010
20170—028
20180—022
20190—015
20200—03
20210—02
20220—018
20230—060
20240—080
20250—0170
20260—0—

More from Ssi Medical Services, Inc.

6 FDA decisions under this applicant name. See the company

  • K943385Clinitron ElexisSsi Medical Services, Inc. · 1995
  • K942184Clinitron at Home Air Fluided TherapySsi Medical Services, Inc. · 19952 recalls
  • K914351Clinitron C-10Ssi Medical Services, Inc. · 1992
  • K882161Acucair Cushion Continuous Airflow SystemSsi Medical Services, Inc. · 1988
  • K863047FlexicairSsi Medical Services, Inc. · 19865 recalls

Recent decisions in INX

The INX category page

  • K972176Home Care Bead BedKinetic Concepts, Inc. · 1998
  • K964223Clinitron Rite-HiteHill-Rom, Inc. · 19972 recalls
  • K943385Clinitron ElexisSsi Medical Services, Inc. · 1995
  • K942184Clinitron at Home Air Fluided TherapySsi Medical Services, Inc. · 19952 recalls
  • K931168X-20 Air Support BedAmerican Life Support Technology, Inc. · 1994

https://510kreport.com/device/K890523 · printed Nov 4, 2026

Cite this page

510(k) Report. “K890523: Supercair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890523

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