Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

The Medical Group, Inc. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

32 daysmedian FDA review time
77 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K911246THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2The Medical Group, Inc.1991-06-06770
K901295PULMONAIR 40 PATIENT MANAGEMENT SYSTEMThe Medical Group, Inc.1990-03-30100
K881843PEDIATRIC HOSPITAL BEDThe Medical Group, Inc.1988-10-261770
K881844MAGNUM 800(TM) MANAGEMENT SYSTEMThe Medical Group, Inc.1988-07-14730
K870284TRIANGULAR BANDAGEThe Medical Group, Inc.1987-02-24280
K8702833 X 3 SPONGES, NON-STERILEThe Medical Group, Inc.1987-02-24280
K8702824 X 4 SPONGES, NON-STERILEThe Medical Group, Inc.1987-02-24280
K870285THERMOMETER SHEATHES, STERILE (GLASS)The Medical Group, Inc.1987-02-12160
K863767GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.1986-10-30350
K863769EVACUATOR TIPSThe Medical Group, Inc.1986-10-30350
K863766DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.1986-10-30350
K863768SALIVA EJECTORSThe Medical Group, Inc.1986-10-27320
K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc.1986-10-27322
K863774CONTOUR CUP MASKSThe Medical Group, Inc.1986-10-24290
K8637602X2 SPONGES, NON-STERILEThe Medical Group, Inc.1986-10-24290
K8637612X2 SPONGES, NON-STERILE, COTTON FILLEDThe Medical Group, Inc.1986-10-24290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda