510(k) Report

510(k) · Cleared

Cleared

Model OB-500 Fetal Growth Analysis & Option Oblink

K900271510(k) TraditionalCleared Apr 19, 199090-day reviewClass II21 CFR 884.2225

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

Digisonics, Inc. · HEM Imager, Ultrasonic Obstetric-Gynecologic

Cleared on Apr 19, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 19, 1990
Review
90 days
Class
Class II
Product code
HEM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K900271Source: 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.

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  • 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 HEM devices

HEM Imager, Ultrasonic Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HEM

FDA has decided no HEM device since 2007.

Median 510(k) review, days · HEM

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

Recalls per year · HEM

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HEM

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code HEM, 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—00
20080—10
20090—00
20100—00
20110—00
20120—01
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 Digisonics, Inc.

3 FDA decisions under this applicant name. See the company

  • K970402Doctors Review SystemDigisonics, Inc. · 19975 recalls
  • K800766Echo-CompDigisonics, Inc. · 1980

Recent decisions in HEM

The HEM category page

  • K951393Abacus OB Ultrasoung Computer SoftwareSolomon Technology Labs · 1995
  • K942490Babe Computer Pogram for Obstetric UltrasoundMedical Soft, Inc. · 1995
  • K910426Sdu 500 Diagnostic Ultrasound InstrumentShimadzu Medical Systems · 1991
  • K905000Aloka Ust-964P-5 Endovaginal TransducerCorometrics Medical Systems, Inc. · 1991
  • K900505Sonoace 88 Portable Ultrasound ScannerMedison Co., Ltd. · 1990

https://510kreport.com/device/K900271 · printed Nov 3, 2026

Cite this page

510(k) Report. “K900271: Model OB-500 Fetal Growth Analysis & Option Oblink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K900271

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