510(k) Report

510(k) · Cleared

Cleared

Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073

K002912510(k) TraditionalCleared Feb 21, 2001156-day reviewClass II21 CFR 884.4530

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

Sterinc · HIB Speculum, Vaginal, Nonmetal

Cleared on Feb 21, 2001 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 21, 2001
Review
156 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK002912 Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073Sterinc · 2001
  2. Descendant · cites it directly · 1 of its ownK092534 Alatus Vaginal Balloon Packing SystemRadiadyne · 2009
  3. Descendant · 2 generations on · 0 of its ownK120344 Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K092534Alatus Vaginal Balloon Packing SystemRadiadyne · 2009 · cites it directly1descendant
  • K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002912Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073Sterinc2001—
+1K092534Alatus Vaginal Balloon Packing SystemRadiadyne2009—
+2K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer)2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
FIG. 1 — Lineage of K002912, 2001–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HIB device

  1. #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
Get a 510(k) Report

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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092534Alatus Vaginal Balloon Packing SystemRadiadyne20091

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?

  • Of its descendants, K092534 (Radiadyne, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HIB devices

HIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIB

2in 2014

2007: 12008: 22009: 12010: 12011: 12012: 12013: 12014: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIB

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

Recalls per year · HIB

1in 2015

2015: 12026 (partial year): 1
2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · HIB

3in 2025

2007: 12008: 22009: 12010: 102011: 152012: 152013: 92014: 82015: 52016: 22017: 52018: 32019: 42020: 42021: 42022: 22023: 32024: 22025: 3
2007high 15 (2011) · low 1 (2007)2025

MAUDE reports naming product code HIB, 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
20071—01
20082—02
20091—01
20101—010
20111—015
20121—015
20131—09
20142—08
20150—15
20160—02
20170—05
20180—03
20190—04
20200—04
20210—04
20220—02
20230—03
20240—02
20250—03
20261—1—

Recent decisions in HIB

The HIB category page

  • K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026
  • K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
  • K132668Iob Disposable SpeculumIob Medical, Inc. · 2014
  • K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall

https://510kreport.com/device/K002912 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002912: Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002912

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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