510(k) Report

510(k) · Decided

Decided

Psa Series

K123916510(k) TraditionalDecided Apr 9, 2013111-day reviewClass II21 CFR 870.3600

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

Osypka Medical, Inc. · DTE Pulse-Generator, Pacemaker, External

Cleared on Apr 9, 2013 as substantially equivalent to K964190 (Biotronik, Inc., 1997) after a 111-day review. Its family tree reaches back 2 generations to 1988.

Decided
Apr 9, 2013
Review
111 days
Class
Class II
Product code
DTE
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K883930 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1989: 1 other ancestorK883930 · Seamed Model 3300 Dual Chamber Pacing System Analy · Seamed Corp. · 1988K964190 · Era 300 Dual Chamber Pacing System Analyzer · Biotronik, Inc. · 19971985199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor K964190 · Era 300 Dual Chamber Pacing System Analyzer · Biotronik, Inc. · 1997K883930 · Seamed Model 3300 Dual Chamber Pacing System Analy · Seamed Corp. · 19880
  1. Root · 2 generations backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
  2. 1 generation backK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
  3. This deviceK123916 Psa SeriesOsypka Medical, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K883930Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp.1988—
−1K964190Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc.1997—
0 (this device)K123916Psa SeriesOsypka Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
FIG. 1 — Lineage of K123916, 1988–2013Source: 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 DTE? 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 DTE device

  1. #1 K232721 Lifetech Cardio Temporary Pacemakerscore 7.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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
*K964190Era 300 Dual Chamber Pacing System Analyzer
Summary page 1
…37 Device PSAW Series, PSA 200TM and PSA 100TM Pacing System Analyzer Trade Name: Predicate Biotronik ERA 300 Dual Chamber Pacing System Analyzer (K964190) Device: Device PSA TM Series devices are portable pacing system analyzers, which are intended Description: to be…
Biotronik, Inc.1997—

Also cleared against K964190: 4 other devices →

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?

  • The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 15.7 years on median.
  • None of the 3 ancestors has a recall.
  • 4 other devices also cite its predicate K964190.

How does its category compare?

All DTE devices

DTE Pulse-Generator, Pacemaker, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · DTE

1in 2025

2013: 22015: 12016: 22018: 22019: 22020: 12024: 12025: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTE

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

Recalls per year · DTE

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DTE

636in 2025

2007: 172008: 222009: 392010: 3352011: 1,8652012: 1,7862013: 982014: 672015: 3422016: 4962017: 6542018: 9562019: 1,0012020: 1,0922021: 8992022: 8332023: 6502024: 6202025: 636
2007high 1,865 (2011) · low 17 (2007)2025

MAUDE reports naming product code DTE, 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—017
20080—022
20090—039
20100—2335
20110—01,865
20120—01,786
20132—098
20140—067
20151—0342
20162—0496
20170—0654
20182—0956
20192—01,001
20201—01,092
20210—0899
20220—0833
20230—0650
20241—0620
20251—0636
20260—0—

What is it indicated for?

This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.

Indications for use as stated in the FDA summary.

Also cleared against K964190

4 other devices cite the same predicate.

  • K073230Models Era 300 and 3105 Pacing System AnalyzersBiotronik, Inc. · 2007
  • K050884Adapter CableRemington Medical, Inc. · 20051 recall
  • K033613Modification to Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 2003
  • K022360Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000 Battery (Type 2); NK-11…Biotronik, Inc. · 2003

More from Osypka Medical, Inc.

7 FDA decisions under this applicant name. See the company

  • K082242Icon, Model C3Osypka Medical, Inc. · 2008
  • K081035Aesculon C2, Aesculon CHF Clinic C2, Aesculon Hypertension Clinic C2 and Aesculon Pacemaker Clinic C2Osypka Medical, Inc. · 2008
  • K070985Aesculon CHF, Hypertension & Pacemaker ClinicOsypka Medical, Inc. · 2008
  • K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc. · 2003
  • K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and…Osypka Medical, Inc. · 2002

Recent decisions in DTE

The DTE category page

  • K241781Solo Pace ControlSolo Pace, Inc. · 2025
  • K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2024
  • K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2020
  • K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc. · 2019
  • K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019

https://510kreport.com/device/K123916 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123916: Psa Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123916

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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