510(k) Report

510(k) · Cleared

Cleared

Spectrum-10

K831655510(k) TraditionalCleared Jun 17, 198325-day reviewClass I21 CFR 866.2660

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

Austin Biological Laboratories · JSZ Kit, Identification, Pseudomonas

Cleared on Jun 17, 1983 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 17, 1983
Review
25 days
Class
Class I
Product code
JSZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831655Source: 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 JSZ? 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 JSZ devices

JSZ Kit, Identification, Pseudomonas: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JSZ

FDA has decided no JSZ device since 2007.

Median 510(k) review, days · JSZ

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

Recalls per year · JSZ

No recall names JSZ since 2007.

Adverse event reports per year · JSZ

No MAUDE report names JSZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Austin Biological Laboratories

45 FDA decisions under this applicant name. See the company

  • K880511Xact NeisseriaAustin Biological Laboratories · 1988
  • K874727Precept (TM) CiprofloxacinAustin Biological Laboratories · 1988
  • K870769Austin Nonfermenter KitAustin Biological Laboratories · 1987
  • K864069Precept (TM) Ticarcillin/Clavulanic AcidAustin Biological Laboratories · 1986
  • K862560Precept CeftizoximeAustin Biological Laboratories · 1986

https://510kreport.com/device/K831655 · printed Nov 4, 2026

Cite this page

510(k) Report. “K831655: Spectrum-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K831655

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